BD PHASEAL¿ INJECTOR LUER LOCK N35
Report
- Report Number
- 3003152976-2022-00273
- Event Type
- Malfunction
- Date Received
- June 17, 2022
- Date of Event
- May 23, 2022
- Report Date
- August 11, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- UDI-DI
- 30382905150037
- PMA / PMN Number
- K140591
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS SUSPECTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2112006. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. DEVICE MANUFACTURE DATE: 03-DEC-2021. MEDICAL DEVICE LOT #: 2111009. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024. DEVICE MANUFACTURE DATE: 18-NOV-2021. MEDICAL DEVICE LOT #: 2110011. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024. DEVICE MANUFACTURE DATE: 25-OCT-2021. MEDICAL DEVICE LOT #: 2111012. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024. DEVICE MANUFACTURE DATE: 30-NOV-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 09-JUN-2022. H6: INVESTIGATION SUMMARY: MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL PRODUCT WAS INSPECTED, NO DAMAGE WAS OBSERVED ON THE PRODUCT AND ALL LUER DIMENSIONS WERE VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTORS TO A SYRINGE AND PROTECTOR ACCORDING TO THE INSTRUCTIONS FOR USE. IN ALL CASES, LIQUID INSIDE THE SYRINGE COULD MOVE TO THE VIAL AND BACK TO THE SYRINGE WITHOUT ISSUE AND NO DISCONNECTIONS BETWEEN THE LUER CONNECTION WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 2112006, 2111012, 2111009, AND 2110011, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD PHASEAL¿ INJECTORS LUER LOCK N35 WOULD NOT STAY THREADED ONTO THEIR ALARIS TUBING SETS WHILE TRANSPORTING THEM TO NURSING, CAUSING CHEMOTHERAPY LEAKAGE IN SOME CASES. LOTS 2112006, 2111009, 2110011, AND 2111012 WERE SUSPECTED OF BEING INVOLVED IN THE EVENT, BUT NO FURTHER CLARIFYING INFORMATION HAS BEEN RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A NUMBER OF CHEMOTHERAPY SPILLS IN THE LAST 2 WEEKS AND FOR SURE THE TWO MOST RECENT HAVE BEEN RELATED TO THE PHASEAL CONNECTORS NOT STAYING THREADED." "WHEN I MET WITH THE PHARMACY TECHNICIANS TO REVIEW CLINICAL PRACTICE RELATED TO ATTACHING THE INJECTOR TO ALARIS TUBING WITH SPIN COLLARS I NOTICED THEY ALL DID NOT ATTACH PROPERLY BY PULLING THE SPIN COLLAR BACK, INSERTING THE MALE LUER INTO THE FEMALE END OF THE INJECTOR, GIVING IT A QUARTER TURN AND THEN SECURING SPIN COLLAR ONTO THE INJECTOR. I PROVIDED RE-TRAINING AND EDUCATION. NO REPORTED ADVERSE INCIDENT WAS REPORTED TO ME. THEY JUST STATED THAT THE INJECTOR WOULD FALL OFF THE TUBING DURING TRANSPORT TO NURSING FOR ADMINISTRATION."
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD PHASEAL¿ INJECTORS LUER LOCK N35 WOULD NOT STAY THREADED ONTO THEIR ALARIS TUBING SETS WHILE TRANSPORTING THEM TO NURSING, CAUSING CHEMOTHERAPY LEAKAGE IN SOME CASES. LOTS 2112006, 2111009, 2110011, AND 2111012 WERE SUSPECTED OF BEING INVOLVED IN THE EVENT, BUT NO FURTHER CLARIFYING INFORMATION HAS BEEN RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A NUMBER OF CHEMOTHERAPY SPILLS IN THE LAST 2 WEEKS AND FOR SURE THE TWO MOST RECENT HAVE BEEN RELATED TO THE PHASEAL CONNECTORS NOT STAYING THREADED." "WHEN I MET WITH THE PHARMACY TECHNICIANS TO REVIEW CLINICAL PRACTICE RELATED TO ATTACHING THE INJECTOR TO ALARIS TUBING WITH SPIN COLLARS I NOTICED THEY ALL DID NOT ATTACH PROPERLY BY PULLING THE SPIN COLLAR BACK, INSERTING THE MALE LUER INTO THE FEMALE END OF THE INJECTOR, GIVING IT A QUARTER TURN AND THEN SECURING SPIN COLLAR ONTO THE INJECTOR. I PROVIDED RE-TRAINING AND EDUCATION. NO REPORTED ADVERSE INCIDENT WAS REPORTED TO ME. THEY JUST STATED THAT THE INJECTOR WOULD FALL OFF THE TUBING DURING TRANSPORT TO NURSING FOR ADMINISTRATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194940 | BD PHASEAL¿ INJECTOR LUER LOCK N35 | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 515003 | SEE SECTION H10 | 30382905150037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | UNSPECIFIED BD ALARIS TUBING SET |