BD 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE
Report
- Report Number
- 1911916-2023-00665
- Event Type
- Malfunction
- Date Received
- September 14, 2023
- Date of Event
- August 29, 2023
- Report Date
- September 25, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- GAA
- UDI-DI
- 00382903052011
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- 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: 13-SEP-2023. INVESTIGATION SUMMARY: IT WAS REPORTED THE BOX IS WRAPPED IN PLASTIC AND IS SOAKED IN WHAT SMELLS LIKE VINEGAR. TO AID IN THE INVESTIGATION, ONE CASE BOX IN A PLASTIC BAG AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE CARDBOARD OF THE CASE BOX RECEIVED IS WET AND HAS A STRONG SMELL LIKE VINEGAR. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE TRANSPORTATION OR STORAGE OF THE UNIT. THE PRODUCT RECEIVED IS NOT IN THE CONDITION THE PRODUCT LEAVES THE MANUFACTURING FACILITY. AT THE MANUFACTURING SITE, THE CASE BOXES ARE NOT WRAPPED IN PLASTIC BAGS AS IT WAS REPORTED WHEN RECEIVED. A NOTIFICATION TO THE DISTRIBUTION CENTER WAS MADE REGARDING THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 3083412. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE EXPERIENCED SHIPPING BOX OR INSIDE UNITS ARE WET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER GOT IN A CASE FROM BD THAT HAS 4 CASES INSIDE: 2 CASES OF 303018, 1 CASE OF 381167, 1 CASE OF 305201. THE CASE OF 305201 IS WRAPPED IN PLASTIC, THE BOX IS SOAKED IN WHAT SMELLS LIKE VINEGAR. THE MAIN BOX ISN¿T A REPACK BOX AND IT¿S NOT WET.
IT WAS REPORTED THAT THE BD 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE EXPERIENCED SHIPPING BOX OR INSIDE UNITS ARE WET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER GOT IN A CASE FROM BD THAT HAS 4 CASES INSIDE: 2 CASES OF 303018, 1 CASE OF 381167, 1 CASE OF 305201. THE CASE OF 305201 IS WRAPPED IN PLASTIC, THE BOX IS SOAKED IN WHAT SMELLS LIKE VINEGAR. THE MAIN BOX ISN¿T A REPACK BOX AND IT¿S NOT WET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2282593 | BD 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE | FILTER NEEDLE | GAA | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 3083412 | 00382903052011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |