BD Luer Tip Caps 308341Recalls & reported problems
Becton, Dickinson And Company · CAP TIP SYR LL/LS STER LF BLACK 10/TRAY · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903083412), received between Aug 31, 2018 and Dec 8, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 14, 2025Open, Classified
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Z-0504-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Loose or Intermittent Connection2
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATIN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18290253 ↗MalfunctionSep 7, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT CAP TIP SYR LL/LS STER LF BLACK 10/TRAY CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED FIBERS COMING OFF OF THE PACKAGING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12436065 ↗MalfunctionAug 31, 2018Loose or Intermittent Connection
IT WAS REPORTED THAT BD¿ TIP CAP TRAYS HAVE TIP CAPS THAT WILL NOT STAY ON THE IV SYRINGES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7837363 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.