BD MICROLANCE¿ 3 NEEDLE
Report
- Report Number
- 3002682307-2023-00203
- Event Type
- Malfunction
- Date Received
- July 24, 2023
- Date of Event
- June 30, 2023
- Report Date
- October 4, 2023
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 25-SEP-2023. H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 220513. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, A NEEDLE PRODUCT WITH SOME EXTRA PACKAGING FILM STUCK WITHIN THE BLISTER PACKAGE WAS OBSERVED. A SEALING TEST WAS PERFORMED AND IT WAS CONFIRMED THAT THE PACKAGE SEAL WAS WITHIN SPECIFICATION. ALTHOUGH THE FOREIGN MATERIAL WAS CONFIRMED WITHIN PART OF THE PACKAGE SEAL, IT DID NOT AFFECT THE SEAL OR THE STERILITY OF THE PRODUCT. THE PRIMARY PACKAGE FOR THIS PRODUCT CONSISTS OF FILM AND PAPER WEB WHICH ARE SEALED THROUGH THE USE OF PRESSURE AND TEMPERATURE. IN ORDER TO MOVE THE BLISTER STRIPS THROUGH THE PROCESS, A PAIR OF METAL CLIPS IS USED. IT HAS BEEN CONCLUDED THAT A SMALL PIECE OF FILM BROKE AND REMAINED IN A METAL CLIP, THIS FILM PIECE BECAME DIRTY FROM THE MACHINERY GREASE. AS A PREVENTIVE MEASURE, THE PACKAGING MACHINERY HAS A DETECTION SYSTEM IN PLACE TO DETECT ANY PAPER/FILM BREAKAGE AND TO STOP THE PROCESS AUTOMATICALLY IF DETECTED. FOR THIS CASE, THE FILM APPEARS TO HAVE BEEN BROKEN BUT NOT THE PAPER, SO THE DETECTION SYSTEM DID NOT STOP AND THE PIECE OF FILM WAS RE-CIRCULATED IN THE PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. INITIAL REPORTER PHONE #:(B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE HAD AN OILY LOOKING FILM THAT COMPROMISES THE PACKAGE SEALING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: THE FOLLOWING DEFECT HAS BEEN OBSERVED: AN OILY-LOOKING PIECE OF FILM (PRESUMABLY A REMNANT OF THE PE FILM THAT IS CUT OFF AFTER THE SEALING PROCESS) INTERRUPTS THE SEALING SEAM. THIS RESULTS IN A NON-STERILE PRODUCT.
IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE HAD AN OILY LOOKING FILM THAT COMPROMISES THE PACKAGE SEALING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: THE FOLLOWING DEFECT HAS BEEN OBSERVED: AN OILY-LOOKING PIECE OF FILM (PRESUMABLY A REMNANT OF THE PE FILM THAT IS CUT OFF AFTER THE SEALING PROCESS) INTERRUPTS THE SEALING SEAM. THIS RESULTS IN A NON-STERILE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422955 | BD MICROLANCE¿ 3 NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON, S.A. | 220513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |