BD PHASEAL¿ INJECTOR LUER LOCK N35
Report
- Report Number
- 3003152976-2018-00342
- Event Type
- Malfunction
- Date Received
- August 6, 2018
- Date of Event
- July 18, 2018
- Report Date
- August 16, 2018
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- UDI-DI
- 30382905150037
- PMA / PMN Number
- K140591
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
A TOTAL OF EIGHT INJECTOR SAMPLES, TWO FOR EACH LOT NUMBER REPORTED, WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. IN ADDITION TO THE REPRESENTATIVE SAMPLES, PICTURE SAMPLES WERE PROVIDED AND TWO PROTECTORS WERE RETURNED. UPON EXAMINATION OF THE PICTURE SAMPLES, DROPS WERE OBSERVED ON THE SURFACE OF THE INJECTOR SAFETY SLEEVE. VISUAL INSPECTION OF THE PROVIDED PHYSICAL SAMPLES DID NOT REVEAL ANY DEFECTS OR ABNORMALITIES. FUNCTIONALITY TESTING WAS PERFORMED AND LEAKAGE WAS NOT FOUND WITH ANY OF THE INJECTOR SAMPLES. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. THE DEFECT WAS CONFIRMED BUT IT COULDN¿T BE DUPLICATED. NO DEFECTS WERE FOUND IN SAMPLES RECEIVED AND NO NON-CONFORMANCES WERE FOUND DURING DHR REVIEW. IT IS NO POSSIBLE TO ESTABLISH A PROBABLE ROOT CAUSE.
DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.
IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35 THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD PHASEAL INJECTOR LUER LOCK N35 THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1803104; MEDICAL DEVICE EXPIRATION DATE: 2020-08-31; DEVICE MANUFACTURE DATE: 2018-03-14; MEDICAL DEVICE LOT #: 1805112; MEDICAL DEVICE EXPIRATION DATE: 2020-10-31; DEVICE MANUFACTURE DATE: 2018-05-28; MEDICAL DEVICE LOT #: 1803101; MEDICAL DEVICE EXPIRATION DATE: 2020-08-31; DEVICE MANUFACTURE DATE: 2018-03-05; MEDICAL DEVICE LOT #: 1801105; MEDICAL DEVICE EXPIRATION DATE: 2020-06-30; DEVICE MANUFACTURE DATE: 2018-01-15. INVESTIGATION: A TOTAL OF EIGHT INJECTOR SAMPLES, TWO FOR EACH LOT NUMBER REPORTED, WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. IN ADDITION TO THE REPRESENTATIVE SAMPLES, PICTURE SAMPLES WERE PROVIDED AND TWO PROTECTORS WERE RETURNED. UPON EXAMINATION OF THE PICTURE SAMPLES, DROPS WERE OBSERVED ON THE SURFACE OF THE INJECTOR SAFETY SLEEVE. VISUAL INSPECTION OF THE PROVIDED PHYSICAL SAMPLES DID NOT REVEAL ANY DEFECTS OR ABNORMALITIES. FUNCTIONALITY TESTING WAS PERFORMED AND LEAKAGE WAS NOT FOUND WITH ANY OF THE INJECTOR SAMPLES. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE DEFECT WAS CONFIRMED BUT IT COULDN¿T BE DUPLICATED. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.
IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35 THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592245 | BD PHASEAL¿ INJECTOR LUER LOCK N35 | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | SEE H.10 | 30382905150037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |