BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
Report
- Report Number
- 1024879-2023-00111
- Event Type
- Malfunction
- Date Received
- February 23, 2023
- Date of Event
- February 14, 2023
- Report Date
- May 23, 2023
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- PMA / PMN Number
- K991088
- 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 ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES; D9: RETURNED TO MANUFACTURER ON: 2023-03-02. THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THERE WAS POOR SLEEVE FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A DAMAGE ON THE SLEEVE WAS FOUND (THE TIP OF NP-NEEDLE WAS PROTRUDING."
H.6 INVESTIGATION SUMMARY "MATERIAL #: 367300; LOT/BATCH #: 2160096. BD RECEIVED 1 SAMPLE AND 6 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SIDE-PIERCED SLEEVE WAS OBSERVED. THE CUSTOMER SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR SIDE-PIERCED SLEEVE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 30 VACUTAINER TUBES, AND THE ISSUE OF SIDE-PIERCED SLEEVE WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE SIDE-PIERCED SLEEVE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THERE WAS POOR SLEEVE FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A DAMAGE ON THE SLEEVE WAS FOUND (THE TIP OF NP-NEEDLE WAS PROTRUDING)."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THE SHIELDS AND/OR PROTECTIVE CAP COMES OFF, NEEDLESTICK INJURY - CLEAN NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS IS A REPORT ABOUT A MISSING SHIELD OF LUER ADAPTER. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, WITHOUT THE SHIELD, THE NEEDLE WAS FOUND TO BE EXPOSED BEFORE USE."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THE SHIELDS AND/OR PROTECTIVE CAP COMES OFF, NEEDLESTICK INJURY -CLEAN NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS IS A REPORT ABOUT A MISSING SHIELD OF LUER ADAPTER. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, WITHOUT THE SHIELD, THE NEEDLE WAS FOUND TO BE EXPOSED BEFORE USE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 444428 | BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 2160096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |