ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
Report
- Report Number
- 1917413-2022-00459
- Event Type
- Malfunction
- Date Received
- August 3, 2022
- Date of Event
- June 16, 2022
- Report Date
- August 8, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- PMA / PMN Number
- SEE H.10.
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K070820. PMA / 510(K)#: K070822. PMA / 510(K)#: K080751. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: D.9 DEVICE AVAILABLE FOR EVAL? YES. RETURNED TO MANUFACTURER ON - 07/13/2022. H.6 INVESTIGATION SUMMARY BD RECEIVED 1000 SAMPLES (1 CASE) AND 5 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. A VISUAL EXAMINATION OF THE SAMPLE AND PHOTOS WAS PERFORMED AND REVEALED DAMAGE TO THE SHELF LABEL, TORN SHRINKWRAP, AND UPSIDE-DOWN TUBE IN SHELF PACK. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE SAMPLES AND PHOTOS PROVIDED. THE EXACT CAUSE OF THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BASED ON AN EVALUATION OF FREQUENCY AND SEVERITY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED WHEN USING THE ABBOTT TUBE EDTA PLH 13X75 2.0 PNK PRODUCT, THE DEVICE EXPERIENCED MISSING COMPONENT OF PRODUCT. THIS EVENT OCCURRED 213 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED EDTA MULTIPLE DEFECTS LIKE DAMAGED LABELS (RIPPED, WRINKLED, MISSING), CALL ACTIVITY COMMENT: CUSTOMER PROBLEM: CUSTOMER REPORTS MULTIPLE DEFECTS LIKE DAMAGED LABELS (RIPPED, WRINKLED, MISSING), STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THIS IS THE SECOND SHIPMENT FROM THE SAME LOT THAT CUSTOMER REPORTS ISSUES WITH. PLEASE REFER TO CASE 1712675 FOR FIST COMPLAINT. PER CUSTOMER, THE SECOND SHIPMENT HAD THE SAME DEFECT AS THE FIRST SHIPMENT. CUSTOMER STATES THE LABELS ON THE OUTSIDE OF THE 197 SHELF PACKS WERE DAMAGED (RIPPED, WRINKLED, MISSING). DID THE SPECIMEN(S) NEED TO BE RECOLLECTED?: N/A. DID EXPOSURE TO BLOOD/ BF OCCUR? N/A. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? N/A NEXT STEPS (IF NECESSARY):DOCUMENT COMPLAINT. FOLLOW UP EMAIL SENT TO CUSTOMER. RESOLUTION ACHIEVED (Y/N)? : N. QUANTITY RECEIVED AND QUANTITY AFFECTED: 7310 SHELF PACKS RECEIVED, 213 SHELF PACKS AFFECTED. (B)(6) : 2022-07-06 17:32:22 (GMT) CUSTOMER REPORTS MULTIPLE .DEFECTS LIKE DAMAGED LABELS (RIPPED, WRINKLED, MISSING).
IT WAS REPORTED WHEN USING THE ABBOTT TUBE EDTA PLH 13X75 2.0 PNK PRODUCT, THE DEVICE EXPERIENCED MISSING COMPONENT OF PRODUCT. THIS EVENT OCCURRED 213 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED EDTA MULTIPLE DEFECTS LIKE DAMAGED LABELS (RIPPED, WRINKLED, MISSING).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2137164 | ABBOTT TUBE EDTA PLH 13X75 2.0 PNK | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 2048364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |