SEE H.10
Report
- Report Number
- 2243072-2023-01450
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- August 9, 2023
- Report Date
- September 14, 2023
- Manufacturer
- BD CARIBE LTD.
- Product Code
- JKA
- UDI-DI
- 50382903649025
- PMA / PMN Number
- K991088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BD CARIBE LTD. ¿ JUNCOS PR / 00777. D.4. MEDICAL DEVICE LOT #: 3053164. D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. G.1 MANUFACTURING LOCATION: BD CARIBE LTD. ¿ JUNCOS PR / 00777. H.4. DEVICE MANUFACTURE DATE: 18-APR-2023. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNABLE TO DISCONNECT WAS OBSERVED. ADDITIONALLY, 48 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF UNABLE TO DISCONNECT WAS NOT OBSERVED AS NO DEFECTS WERE FOUND WITH THE HUB. 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 UNABLE TO DISCONNECT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.
D.3 COMMON DEVICE NAME: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER. D4. MEDICAL DEVICE LOT #: UNKNOWN . D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H4. DEVICE MANUFACTURE DATE: UNKNOWN . H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
(B)(6) : 2023-09-01 13:09:23 (GMT). REVIEWED, PENDING INVESTIGATION SUMMARY. (B)(6) : 2023-08-28 19:38:17 (GMT). CUSTOMER DID NOT RESPOND AFTER MULTIPLE ATTEMPTS TO CONTACT FOR RETURNS. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) : 2023-08-23 13:25:51 (GMT). SUBJECT: EMAIL 8/23/2023, 8:23:02 AM USER: (B)(6) CREATED ON: 2023-08-23 13:23:02 CALL ACTIVITY COMMENT: FINAL FOLLOW UP FOR RETURNS. KIMBERLY JACKSON : 2023-08-21 12:29:57 (GMT). SUBJECT: EMAIL 8/21/2023, 7:25:23 AM. USER: (B)(6). CREATED ON: 2023-08-21 12:25:24. CALL ACTIVITY COMMENT: 1ST FOLLOW UP FOR RETURNS. (B)(6): 2023-08-17 12:22:45 (GMT). SUBJECT: EMAIL 8/17/2023, 7:00:29 AM. USER: (B)(6). CREATED ON: 2023-08-17 12:00:30. CALL ACTIVITY COMMENT: FEDEX RETURN LABEL SENT. KIMBERLY JACKSON : 2023-08-17 12:10:59 (GMT) FEDEX RETURN: 773081660949 (B)(6) : 2023-08-16 17:49:25 (GMT). SUBJECT: EMAIL 8/16/2023, 12:16:59 PM. USER: (B)(6). CREATED ON: 2023-08-16 17:17:00. CALL ACTIVITY COMMENT: FINAL REQUEST IF RETURNS ARE AVAILABLE (B)(6) : 2023-08-14 16:54:51 (GMT). SUBJECT: EMAIL 8/14/2023, 9:54:16 AM. USER: (B)(6) CREATED ON: 2023-08-14 14:54:16 CALL ACTIVITY COMMENT: ASKED IF RETURNS AVAILABLE (B)(6) : 2023-08-14 15:26:02 (GMT). DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? NO. DID EXPOSURE TO BLOOD/ BF OCCUR? NO. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? NA. QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 AFFECTED. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): UNKNOWN. IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD¿ WHO IS IT? UNKNOWN. (B)(6) : 2023-08-14 14:21:04 (GMT). SUBJECT: EMAIL 8/14/2023, 7:47:04 AM. USER: (B)(6) CREATED ON: 2023-08-14 12:47:05 CALL ACTIVITY COMMENT: 2ND REQUEST FOR INFORMATION (B)(6) : 2023-08-11 12:06:12 (GMT). IF SALESFORCE PIR COMPLAINT, DATE EMAIL RECEIVED: NA. CUSTOMER PROBLEM: CUSTOMER STATES THEY WERE UNABLE TO REMOVE THE VACUTAINER ADAPTER FROM THE BD MAXZERO NEEDLESS CONNECTOR. CUSTOMER BELIEVE THE PROBLEM IS WITH THE MAXZERO ALTHOUGH IT IS NOT CLEAR. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: REQUESTED ADDITIONAL INFORMATION; FACILITY NAME AND ADDRESS, RECOLLECTION, EXPOSURE, INTERVENTION, QUANTITY, DISTRIBUTOR, RETURNS, CREDIT CUSTOMER LOCATION (COUNTRY): USA. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? PENDING. DID EXPOSURE TO BLOOD/ BF OCCUR? PENDING. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? PENDING. NEXT STEPS (IF NECESSARY): AWAITING RESPONSE. RESOLUTION ACHIEVED (Y/N)? : N. QUANTITY RECEIVED AND QUANTITY AFFECTED: 1 AFFECTED. SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): PENDING. IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD¿ WHO IS IT? PENDING. PHOTOS OR RETURNS REQUESTED?: PHOTO OF ADAPTER UNABLE TO DISCONNECT ATTACHED, RETURN REQUESTED. FOLLOW UP REQUIRED (Y/N)?: Y. (B)(6) : 2023-08-11 12:05:58 (GMT). SUBJECT: EMAIL 8/10/2023, 12:01:12 PM. USER: (B)(6). CREATED ON: 2023-08-10 17:01:12. CALL ACTIVITY COMMENT: ADDITIONAL INFORMATION REQUESTED. (B)(6): 2023-08-11 12:00:59 (GMT). SUBJECT: CALL 8/10/2023, 1:31:35 PM. USER: (B)(6). CREATED ON: 2023-08-10 18:31:36. CALL ACTIVITY COMMENT: ADDITIONAL INFORMATION REQUESTED. CALL DROPPED. IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE UNABLE TO REMOVE THE VACUTAINER FROM THE BD MAXZERO NEEDLESS CONNECTOR (B)(6) : 2023-08-11 01:39:06 (GMT) . REVIEWED, PENDING ADDITIONAL INFORMATION. THU AUG 10 17:10:32 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS. (B)(6) : 2023-08-10 17:10:27 (GMT). CUSTOMER STATES THEY ARE UNABLE TO REMOVE THE VACUTAINER FROM THE BD MAXZERO NEEDLESS CONNECTOR.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER THAT THE TUBE IS TIGHT IN HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THEY ARE UNABLE TO REMOVE THE VACUTAINER FROM THE BD MAXZERO NEEDLESS CONNECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 994517 | SEE H.10 | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BD CARIBE LTD. | 3053164 | 50382903649025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |