MedDRA preferred term · a problem with the delivery system

Device delivery system issue: adverse event reports recording this term

25,791 reports to FDA record it, 2012–2026; 0.1% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

25,791
reports recording the term: 0.1% of all reports; 5,680
reports, 12 months to June 2026: 6,002 in the 12 months before; 8.8%
marked serious by the reporter: 57.4% across all reports; 0.2%
record death among outcomes, as reported: 9.1% across all reports

"Device delivery system issue" (in plain words, a problem with the delivery system) is a MedDRA preferred term recorded in 25,791 adverse event reports received by FDA, 0.1% of the database, from June 2012 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

5,680 reports recorded it in the 12 months to June 2026, close to the 6,002 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 8.8% are marked serious, 0.2% include death among the outcomes and 2.6% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Albuterol sulfate, Albuterol and Genotropin. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Albuterol sulfate	beta2-Adrenergic agonist	7,853	17.5%
Albuterol	beta2-Adrenergic agonist	2,727	15.3%
Genotropin	—	2,095	4.7%
Breztri	Corticosteroid	1,533	21.3%
Bydureon Bcise	—	1,461	11.3%
Symbicort	Corticosteroid	1,129	2.9%
Ryaltris	Corticosteroid	701	40.4%
Budesonide Formoterol Glycopyrronium	—	539	11%
Orencia	Selective T cell costimulation modulator	526	0.5%
Levalbuterol tartrate	beta2-Adrenergic agonist	523	71.1%
Airsupra	Corticosteroid	376	38.7%
Cosentyx	Interleukin-17A antagonist	285	0.2%
Neulasta	Leukocyte growth factor	270	0.3%
Semglee	Insulin analog	254	12.5%
Ajovy	—	252	2.5%
Bydureon	—	252	1.3%
Breyna	Corticosteroid	250	40.9%
Qvar Redihaler	Corticosteroid	189	10.9%
Wixela Inhub	Corticosteroid	178	8.9%
Omnitrope	Recombinant human growth hormone	176	1.6%
Enbrel	Tumor necrosis factor blocker	161	0%
Budesonide Formoterol	—	125	4.5%
Fasenra	Interleukin-5 receptor alpha-directed cytolytic antibody	121	0.8%
Genosyl	Vasodilator	117	7.2%
Tremfya	Interleukin-23 antagonist	115	0.4%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
beta2-Adrenergic agonist	11,126	12.1%	1.3%
Corticosteroid	4,574	0.6%	0%
Insulin analog	563	0.2%	0%
Selective T cell costimulation modulator	526	0.4%	0.3%
Leukocyte growth factor	363	0.3%	0%
Interleukin-17A antagonist	300	0.2%	0%
Recombinant human growth hormone	286	1.3%	1.4%
Tumor necrosis factor blocker	266	0%	0%
Anticholinergic	233	0.1%	0%
GLP-1 receptor agonist	156	0%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.2%53

2 to 113.3%859

12 to 173.7%950

18 to 444.2%1,073

45 to 649.7%2,494

65 to 749.1%2,348

75 and over6.4%1,654

Age not given63.4%16,360

Patient sex

Female33.3%8,583

Male23.4%6,035

Not given43.3%11,173

Grey bar: all 20,646,523 reports in the database. 92.1% of these reports give the United States as the country.

Questions about "Device delivery system issue"

What does "Device delivery system issue" mean in an adverse event report?

In plain language: a problem with the delivery system. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record device delivery system issue?

25,791 reports through June 2026 (0.1% of all reports), 5,680 of them in the latest 12 months.

Which drugs appear most often in these reports?

Albuterol sulfate (7,853), Albuterol (2,727), Genotropin (2,095), Breztri (1,533) and Bydureon Bcise (1,461). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.