K991088
Report
- Report Number
- 2618282-2018-00059
- Event Type
- Malfunction
- Date Received
- September 27, 2018
- Date of Event
- September 6, 2018
- Report Date
- October 26, 2018
- Manufacturer
- BD CARIBE LTD.
- Product Code
- JKA
- UDI-DI
- 50382903648806
- PMA / PMN Number
- K991088
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. A ROOT CAUSE COULD NOT BE DETERMINED. BD TECHNICAL SUPPORT SERVICES HAD REACHED OUT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. EDUCATIONAL MATERIAL ON VASCULAR ACCESS AND HEMOLYSIS WAS PROVIDED TO THE CUSTOMER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. A ROOT CAUSE COULD NOT BE DETERMINED. BD TECHNICAL SUPPORT SERVICES HAD REACHED OUT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. EDUCATIONAL MATERIAL ON VASCULAR ACCESS AND HEMOLYSIS WAS PROVIDED TO THE CUSTOMER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT BD VACUTAINER BLOOD TRANSFER DEVICE WITH LUER ADAPTER EXHIBITED HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT BD VACUTAINER BLOOD TRANSFER DEVICE WITH LUER ADAPTER EXHIBITED HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. . A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD VACUTAINER® BLOOD TRANSFER DEVICE WITH LUER ADAPTER EXHIBITED HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754235 | K991088 | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BD CARIBE LTD. | UNKNOWN | 50382903648806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |