BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Report
- Report Number
- 3003152976-2018-00343
- Event Type
- Malfunction
- Date Received
- August 9, 2018
- Date of Event
- July 11, 2018
- Report Date
- October 11, 2018
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: THREE PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE PICTURES, IT CAN BE OBSERVED THAT SYRINGES OF PRODUCT CODE 300867 AND LOT NUMBER 1801232 WERE INSIDE A SHELF PACKAGE WHICH DISPLAYED PRODUCT CODE 300865 AND LOT NUMBER 1803260. A PRODUCTION HISTORY REVIEW FOR PRODUCT CODE 300867 AND LOT NUMBER 1801232 DID NOT REVEAL ANY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. AFTER PRODUCTION, THE LOT WAS SENT FOR STERILIZATION AND WAS DELIVERED TO THE BD WAREHOUSE ON MAY 4TH, 2018 WITH FURTHER SHIPMENT ON MAY 7TH, 2018. A PRODUCTION HISTORY REVIEW FOR PRODUCT CODE 300865 AND LOT NUMBER 1803260 DID NOT REVEAL ANY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. AFTER THE LOT WAS MANUFACTURED, IT WAS SENT FOR STERILIZATION AND WAS DELIVERED TO THE BD WAREHOUSE ON MAY 24TH, 2018 WITH FURTHER SHIPMENT ON MAY 25TH, 2018. BOTH OF THE LOT NUMBERS REPORTED WERE NOT WITHIN BD FACILITIES AT THE SAME TIME. BASED ON THE INVESTIGATION RESULTS, IT IS BELIEVED THAT THE MIXED PRODUCT IS RELATED TO CUSTOMER MANAGEMENT WITHIN THEIR FACILITIES AND IT IS NOT RELATED TO THE BD MANUFACTURING PROCESS.
H.6. INVESTIGATION SUMMARY: IT HAS BEEN RECEIVED 3 PICTURES AND 1 SHELF-PACKAGE OF 50LL LOT 1803260 FOR INVESTIGATION. UPON VISUAL INSPECTION THESE PICTURES AND SAMPLES RECEIVED IT CAN BE OBSERVED SYRINGES OF 50CT REF. 300867 LOT 1801232 INSIDE A SHELF-PACKAGE OF 50LL REF. 300865 LOT 1803260. LOT 1801232 OF REFERENCE 300867 (50CT) WAS MANUFACTURED IN JANUARY 2018. DHR OF LOT 1801232 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DURING MANUFACTURING PROCESS OF THIS LOT NO QUALITY NOTIFICATION WAS OPENED AND NONE REPROCESS WAS DONE THAT COULD BE RELATED WITH THIS MIX PRODUCT. ONCE A LOT HAS BEEN MANUFACTURED IT IS SENT FOR STERILIZATION TO BD (B)(6) PLANT AND AFTER TO BD TEMSE WAREHOUSE ON MAY 4TH, 2018. THIS LOT WAS DELIVERED TO PHARMA ASSIST CUSTOMER ON MAY 7TH, 2018. LOT 1803260 OF REFERENCE 300865 (50LL) WAS MANUFACTURED IN MARCH 2018. DHR OF LOT 1803260 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DURING MANUFACTURING PROCESS OF THIS LOT NO QUALITY NOTIFICATION WAS OPENED AND NONE REPROCESS WAS DONE THAT COULD BE RELATED WITH THIS MIX PRODUCT. ONCE A LOT HAS BEEN MANUFACTURED IT IS SENT FOR STERILIZATION TO BD (B)(6) PLANT AND AFTER TO BD TEMSE WAREHOUSE ON MAY 24TH, 2018. THIS LOT WAS DELIVERED TO PHARMA ASSIST CUSTOMER ON MAY 25TH, 2018. UPON INSPECTION OF THE SHELF-PACKAGE RECEIVED, IT CAN BE OBSERVED THAT THE PRODUCT IS WELL DISPOSED AS IT IS DONE DURING MANUFACTURING PROCESS (BLISTER STRIPES ARE PERFECTLY NESTED) SO, IT IS UNLIKELY THE MIX-UP WAS PRODUCED OUTSIDE MANUFACTURING SITE. INVESTIGATION CONCLUSION: ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH A HUMAN FAILURE IN PACKAGING AREA. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON THE FOLLOWING ASPECTS: ALL PREVENTIVE MIX-UP MEASURES AND OUR STRINGENT LINE CLEARANCE PROCEDURES KEEP MIX UP ISSUES AT LOW LEVELS. NO QUALITY NOTIFICATIONS WERE ISSUES RELATED WITH THE MIXED UP DURING MANUFACTURING OF REPORTED BATCH.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, 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 MANUFACTURE: NO.
IT WAS REPORTED BEFORE USE THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS IN PACKAGE CONTAINER THAT CONTAINED MIXED PRODUCT. THE LABEL SUGGEST THAT THERE SHOULD BE A LL SYRINGES BUT THERE WERE CATHETERTIP SYRINGES THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED BEFORE USE THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS IN PACKAGE CONTAINER THAT CONTAINED MIXED PRODUCT. THE LABEL SUGGEST THAT THERE SHOULD BE A LL SYRINGES BUT THERE WERE CATHETERTIP SYRINGES THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED BEFORE USE THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS IN PACKAGE CONTAINER THAT CONTAINED MIXED PRODUCT. THE LABEL SUGGEST THAT THERE SHOULD BE A LL SYRINGES BUT THERE WERE CATHETERTIP SYRINGES THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED BEFORE USE THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS IN PACKAGE CONTAINER THAT CONTAINED MIXED PRODUCT. THE LABEL SUGGEST THAT THERE SHOULD BE A LL SYRINGES BUT THERE WERE CATHETER TIP SYRINGES THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607531 | BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE | SYRINGE | FMF | BECTON DICKINSON, S.A. | 1803260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |