NEEDLE FILTER BLUNT FILL 18X1
Received Jul 8, 2026 · Event occurred Jun 24, 2026
Report 1911916-2026-00373 · MDR key 25749525
Device
Generic name
Needle, Aspiration And Injection, Disposable
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
305211
Lot number
3181376
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED, NEEDLE FILTER BLUNT FILL 18X1, ADVERSE EVENT INFECTION WITH NO PRODUCT MALFUNCTION. 5 OCCURRENCES. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONFIRMATION OF UQLITY REQUESTED. FIVE CASES OF SEVERE INFECTION WERE REPORTED ASSOCIATED WITH THE USE OF THE SAME LOT. IT IS NOT CERTAIN WHETHER THIS IS A LOT RELATED ISSUE, AS COMPOUNDED ANTISEPTICS WERE ALSO USED AND THE MANUFACTURER HAVE BEEN ALREADY CONTACTED. IT IS BELIEVED IT MAY BE A POSSIBLE DOSAGE OR HANDLING ERROR BY OTHER PROFESSIONALS, BUT WOULD LIKE CONFIRMATION, AS THE PHYSICIANS ARE CONSIDERING SWITCHING THE MEDICATION LOT AS A PRECAUTION.