BD MICRO-FINE¿+ PRO PEN NEEDLE
Report
- Report Number
- 9616656-2022-01322
- Event Type
- Malfunction
- Date Received
- December 6, 2022
- Date of Event
- November 11, 2022
- Report Date
- January 31, 2023
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- UDI-DI
- 00382903205592
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO RECEIVING ADDITIONAL INFORMATION FROM THE CUSTOMER: D.4. MEDICAL DEVICE LOT #: 2060475. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 01-MAR-2022. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NON-PATIENT END OF THE BD MICRO-FINE¿+ PRO PEN NEEDLE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT FROM THE PHARMACIST... WHEN CHECKING THE AFFECTED PRODUCT, THE PHARMACIST NOTICED THAT THE NP SIDE WAS COVERED WITH SOMETHING, WHICH MAY BE ASSOCIATED WITH THE FAILURE FOR THE DRUG SOLUTION TO COME OUT."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NON-PATIENT END OF THE BD MICRO-FINE¿+ PRO PEN NEEDLE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT FROM THE PHARMACIST... WHEN CHECKING THE AFFECTED PRODUCT, THE PHARMACIST NOTICED THAT THE NP SIDE WAS COVERED WITH SOMETHING, WHICH MAY BE ASSOCIATED WITH THE FAILURE FOR THE DRUG SOLUTION TO COME OUT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2596115 | BD MICRO-FINE¿+ PRO PEN NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 2060475 | 00382903205592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |