BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
Report
- Report Number
- 1911916-2022-00430
- Event Type
- Malfunction
- Date Received
- August 15, 2022
- Date of Event
- July 20, 2022
- Report Date
- October 24, 2022
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- NGT
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE SUSPECTED HAIR ITEMS IN THE SALINE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH THE SYRINGE BARREL LABEL PARTIALLY LIFTED UP TO SHOW A BLACK STRING FOREIGN MATTER THAT APPEARS TO BE INSIDE THE SYRINGE. NO OTHER INFORMATION CAN BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER: 306594, LOT NUMBER: 1202153. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 03-OCT-2022. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE SUSPECTED HAIR ITEMS IN THE SALINE. TO AID IN THE INVESTIGATION, ONE EMPTY SAMPLE WITH NO PACKAGING FLOW WRAP AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A BLACK STRING AT THE BOTTOM OF THE SYRINGE BARREL. THE PHOTO SHOWS A SYRINGE WITH THE SYRINGE BARREL LABEL PARTIALLY LIFTED UP TO SHOW A BLACK STRING FOREIGN MATTER THAT APPEARS TO BE INSIDE THE SYRINGE. NO OTHER INFORMATION CAN BE OBTAINED FROM THE PHOTO. THE SAMPLE WAS SENT TO A LABORATORY TO ATTEMPT TO CONFIRM WHAT THE FOREIGN MATTER IS. THE FOREIGN MATTER APPEARED MORE RIGID AND THICKER THAN HUMAN HAIR. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED; HAIR WAS A 74% MATCH AND WHEAT GLUTEN FLOUR WAS AN 85% MATCH. NEITHER ONE OF THESE MATCHES ARE A HIGH ENOUGH PERCENTAGE TO MAKE A DEFINITE CONCLUSION AS TO THE COMPOSITION OF THE FOREIGN MATTER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306594, LOT NUMBER 1202153. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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, BUT THE PROBABLE SOURCE OF THE FOREIGN MATTER IS NOT KNOWN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE SUSPECTED HAIR ITEMS IN THE SALINE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH THE SYRINGE BARREL LABEL PARTIALLY LIFTED UP TO SHOW A BLACK STRING FOREIGN MATTER THAT APPEARS TO BE INSIDE THE SYRINGE. NO OTHER INFORMATION CAN BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306594, LOT NUMBER 1202153. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
CORRECTION: IMDRF ANNEX C GRID: C07.
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE CUSTOMER USED THE FLUSH, HE FOUND THAT THERE WERE SUSPECTED HAIR ITEMS IN THE PHYSIOLOGICAL SALINE."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE CUSTOMER USED THE FLUSH, HE FOUND THAT THERE WERE SUSPECTED HAIR ITEMS IN THE PHYSIOLOGICAL SALINE."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE CUSTOMER USED THE FLUSH, HE FOUND THAT THERE WERE SUSPECTED HAIR ITEMS IN THE PHYSIOLOGICAL SALINE."
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "WHEN THE CUSTOMER USED THE FLUSH, HE FOUND THAT THERE WERE SUSPECTED HAIR ITEMS IN THE PHYSIOLOGICAL SALINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238484 | BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE | SALINE VASCULAR ACCESS FLUSH | NGT | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 1202153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |