B.BRAUN 7M2802Recalls & reported problems
B. Braun Medical Inc. · ALLERGAN 21GA WINGED INF SET · Class U · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964787102), received between Jan 6, 2026 and Jan 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Feb 2, 2026Open, Classified
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Z-1483-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Break2
- Dull, Blunt1
- Material Deformation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2026Break; Dull, Blunt; Material Deformation
ACCORDING TO THE COMPLAINANT, THE NEW NEEDLES HAVE HAD ISSUES, SUCH AS BENDING, BREAKING OFF AND BEING VERY DULL THAT THEY ARE UNABLE TO PUNCTURE THROUGH THE SKIN. NO INJURIES WERE REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066524 ↗MalfunctionJan 6, 2026Break
ACCORDING TO THE COMPLAINANT, THE TE FILL NEEDLES BROKE OFF WHEN USING WITH ALLERGAN FILL KIT. DID NOT BREAK ON THE HUB BUT AT THE BODY OF THE NEEDLE. NEEDLE WAS INSIDE THE PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 23979833 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.