BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
Report
- Report Number
- 3003916417-2023-00090
- Event Type
- Malfunction
- Date Received
- April 21, 2023
- Date of Event
- April 4, 2023
- Report Date
- June 20, 2023
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2151252, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023, H.4. DEVICE MANUFACTURE DATE: 07-JUL-2022; D.4. MEDICAL DEVICE LOT #: 2151253, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023, H.4. DEVICE MANUFACTURE DATE: 07-JUL-2022. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS AND 1 VIDEO WERE PROVIDED FOR INVESTIGATION. THE PHOTOS AND VIDEO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES WAS OBSERVED. ADDITIONALLY, 200 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF GEL AIR BUBBLES WAS OBSERVED. HOWEVER THE ISSUE OF RED CELL HANG UP AND HEMOLYSIS WERE 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 GEL AIR BUBBLES BUT IS UNABLE TO BE CONFIRMED FOR RED CELL HANG UP AND HEMOLYSIS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED THAT DURING USE WITH BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR AIR BUBBLES WERE DISCOVERED IN GEL, THERE WAS ALSO RED CELL HANG UP AND HEMOLYSIS OF SAMPLES OCCURRED. AIR BUBBLES WERE IN 80 TUBES OF LOT# 2151253 AND 28 WITH LOT# 2151252. THERE WERE 4 OCCURRENCES OF RED CELL HANG UP AND HEMOLYSIS WITH LOT# 2151253. PATIENT INFORMATION AND IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: TUBES HAVE AIR BUBBLES IN GEL, IN WHICH WHEN SAMPLE IS COLLECTED, RED CELLS HANG UP THAT AFTER GENERATE HEMOLYSIS IN THE SERUM.
IT WAS REPORTED THAT DURING USE WITH BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR AIR BUBBLES WERE DISCOVERED IN GEL, THERE WAS ALSO RED CELL HANG UP AND HEMOLYSIS OF SAMPLES OCCURRED. AIR BUBBLES WERE IN 80 TUBES OF LOT# 2151253 AND 28 WITH LOT# 2151252. THERE WERE 4 OCCURRENCES OF RED CELL HANG UP AND HEMOLYSIS WITH LOT# 2151253. PATIENT INFORMATION AND IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: TUBES HAVE AIR BUBBLES IN GEL, IN WHICH WHEN SAMPLE IS COLLECTED, RED CELLS HANG UP THAT AFTER GENERATE HEMOLYSIS IN THE SERUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1087870 | BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |