BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR
Report
- Report Number
- 2243072-2018-00127
- Event Type
- Malfunction
- Date Received
- March 14, 2018
- Date of Event
- February 21, 2018
- Report Date
- August 29, 2018
- Manufacturer
- BECTON DICKINSON
- Product Code
- LHI
- PMA / PMN Number
- K972527
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED. DHR REVIEW SHOWED NO NCR-S PRESENT THAT COULD POTENTIALLY EXPLAIN THE ISSUE COSTUMER WAS DESCRIBING. DHR OF THE LOT CONTAINS RESULTS OF THE FUNCTIONAL TESTING ON THE PRODUCT WHICH WAS INTRODUCED AFTER RESTART OF PRODUCTION ON (B)(6) 2017. TRAINING RECORD OF ALL OPERATORS INVOLVED IN PRODUCTION OF THIS LOT AND DISPENSER CHECKUP, AFTER START OF EACH NEW LOT OF THE C61 SECONDARY SET THE DISPENSERS ARE CHECKED FOR FUNCTIONALITY OF ALL PARTS. NO FURTHER INFORMATION WAS GIVEN FROM THE COSTUMER REGARDING THE CIRCUMSTANCES THAT LEAKAGE OCCURRED, DESCRIPTION OF C35 LEAKING FROM SPIKE WOULD BE IMPOSSIBLE AS STATED IN INVESTIGATION. ASSUMPTION THAT COSTUMER WAS ACTUALLY DESCRIBING LEAKAGE ON 6096 PHASEAL AND SPIKE 5328 WAS TAKEN AS BASE OF INVESTIGATION. AFTER INVESTIGATION NO POTENTIAL ROOT CAUSE COULD BE DETERMINATE IF NEW INFORMATION ARRIVES REGARDING THESE COMPLAINTS INVESTIGATION CAN BE REOPENED. C35 CONNECTOR COSTUMER WAS DESCRIBING IS NOT A PART OF C61 SYSTEM/PRODUCT. PHASEAL CONNECTOR ON C61 SYSTEM IS 6096 AND IT SHARES SOME RESEMBLANCE WITH C35 LUER LOCK. OHR FOR LOT 1005467 CONTAINS RESULTS OF FUNCTIONAL TESTING PER ISO 8536, 750 SAMPLES ARE TAKEN EVENLY FROM LOT TO TEST FOR AIR LEAKAGE AND RESULT S ARE CONFORMING. OHR ALSO SHOWS REDUCED FINISHED GOOD QUANTITY FROM (B)(4), THIS IS DUE TO MATERIAL SHORTAGE AND BECAUSE OF THIS TIME TO PRODUCE THE LOT WAS PROLONGED. DISPENSER THAT WAS USED IN THIS PHASE IS ION 346 BUSHING C DUE TO SPECIFIC NATURE OF JOINT THIS DISPENSER IS ONLY USED FOR THIS JOINT. ON (B)(6) 2017 PREVENTIVE MAINTENANCE WAS PERFORMED ON THIS DISPENSER WITHOUT ANY REPLACEMENTS AND WAS CHECKED AGAIN PRIOR TO LOT START (B)(6) 2017.
H.6. INVESTIGATION SUMMARY: THE REPORTED DEFECT OF LEAKAGE AT THE C35 CONNECTOR WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. SAMPLE IS LEAKING ON THE SPIKE-TUBE CONNECTION. UPON REVIEW OF THE PROVIDED LOT NUMBER (1005467) FOR PRODUCT CODE 515302, THERE WERE NO NON-CONFORMANCES REPORTED DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE DEFECT OF LEAKAGE DESCRIBED. DURING PRODUCTION OF THE LOT, PREVENTIVE MAINTENANCE WAS PERFORMED ON THE DISPENSER MACHINERY WITH INSPECTIONS OCCURRING PRIOR TO THE RESTART OF PRODUCTION. DURING THE MANUFACTURING PROCESS, TESTING IS PERFORMED ON THE PRODUCT MATERIALS TO DETECT POTENTIAL SOURCES OF LEAKAGE. THE DISPENSER MACHINERY IS INSPECTED AT THE START OF EACH LOT'S PRODUCTION. BASED ON THE LIMITED CUSTOMER INFORMATION PROVIDED, THE C35 CONNECTOR DESCRIBED IN THE COMPLAINT IS NOT A PART OF THE C61 PRODUCT (PRODUCT CODE: 515302). THE PHASEAL CONNECTOR ON THE C61 SYSTEM SHARES SOME RESEMBLANCE WITH THE C35 LUER LOCK. ASSUMPTION THAT COMPLAINT WAS ACTUALLY DESCRIBING LEAKAGE ON 3096 PHASEAL AND SPIKE 5328 WAS TAKEN AS THE BASE OF THE INVESTIGATION AND A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED. IF NEW INFORMATION ARRIVES REGARDING THESE COMPLAINTS, FURTHER INVESTIGATION CAN BE PERFORMED. BACKGROUND: DHR REVIEW SHOWED NO NCR'S PRESENT THAT COULD POTENTIALLY EXPLAIN ISSUE CUSTOMER WAS DESCRIBING. DHR OF THE LOT CONTAINS RESULTS OF THE FUNCTIONAL TESTING ON THE PRODUCT WHICH WAS INTRODUCED AFTER RESTART OF PRODUCTION ON (B)(6)2017. TRAINING RECORD OF ALL OPERATORS INVOLVED IN PRODUCTION OF THIS LOT AND DISPENSER CHECKUP, AFTER START OF EACH NEW LOT OF THE C61 SECONDARY SET, THE DISPENSERS ARE CHECKED FOR FUNCTIONALITY OF ALL PARTS. DETAILED EXPLANATION IN DEVIATION MEMO WHICH IS ALSO INCLUDED IN DHR. INVESTIGATION CONCLUSIONS: C35 CONNECTOR CUSTOMER IS DESCRIBING IS NOT A PART OF C61 SYSTEM/PRODUCT. PHASEAL CONNECTOR ON C61 SYSTEM IS 6096 AND SHARES SOME RESEMBLANCE WITH C35 LUER LOCK DHR FOR LOT 1005467 CONTAINS RESULTS OF FUNCTIONAL TESTING PER ISO 8536, 750 SAMPLES ARE TAKEN EVENLY FROM LOT TO TEST FOR AIR LEAKAGE AND RESULTS AND CONFORMING. DHR ALSO SHOWED REDUCED FINISHED GOOD QUANTITY, THIS IS DUE TO MATERIAL SHORTAGE AND BECAUSE OF THIS TIME TO PRODUCE THE LOT WAS PROLONGED. DISPENSER THAT WAS USED IN THIS PHASE IS IDN 346 BUSING C DUE TO SPECIFIC NATURE OF JOIN THIS DISPENSER IS ONLY USED FOR THIS JOINT. (B)(6)2017 PREVENTIVE MAINTENANCE WAS PERFORMED ON THIS DISPENSER WITHOUT ANY REPLACEMENTS AND WAS CHECKED AGAIN PRIOR TO LOT START ON (B)(6)2017. ROOT CAUSE DESCRIPTION: MATERIAL: DURING TESTING ON SITE, TEST FOR LEAKAGE WOULD DETECT THIS LACK OF TOLERANCE AS LEAKAGE (OUT OF TOLERANCE PHASEAL CONNECTOR) METHOD: PROCEDURE DESCRIBES THE CORRECT WAY OF ASSEMBLY. MACHINE: UNLIKELY - DISPENSER MALFUNCTION - DISPENSER CHECKUP AT START OF EVERY LOT AND AFTER PAUSES ON THE SAME LOT BY MAINTENANCE OPERATORS. ROOT CAUSE: NO FURTHER INFORMATION WAS GIVEN FROM THE CUSTOMER REGARDING THE CIRCUMSTANCES THAT LEAKAGE OCCURRED, DESCRIPTION OF THE C35 LEAKING FROM THE SPIKE WOULD BE IMPOSSIBLE AS STATED IN INVESTIGATION. ASSUMPTION THAT CUSTOMER WAS ACTUALLY DESCRIBING LEAKAGE ON 3096 PHASEAL AND SPIKE 5328 WAS TAKEN AS BASE OF INVESTIGATION. AFTER INVESTIGATION NO POTENTIAL ROOT CAUSE COULD BE DETERMINED. IF NEW INFORMATION ARRIVES REGARDING THESE COMPLAINTS, INVESTIGATION CAN BE REOPENED.
ADDITIONAL INFORMATION: SAMPLES WERE RECEIVED AND ADDITIONAL TESTING DONE. INVESTIGATION SUMMARY: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UNDERWATER LEAKAGE TESTING WAS PERFORMED ON THE RETURNED SAMPLE AND LEAKAGE OCCURRED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY NON-CONFORMANCES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT OF LEAKAGE. A COMPUTED TOMOGRAPHY SCAN (CT) REVEALED A MOLDING ISSUE WITHIN THE LOCATION OF THE SPIKE COMPONENT WHERE THE TUBING CONNECTS. THE MOLDING DEFECT IS A RESULT OF A MISALIGNED CONNECTION, CAUSING ONE SIDE OF THE COMPONENT WALL TO BE THINNER, RESULTING IN LEAKAGE. FURTHER ACTION HAS BEEN INITIATED, INCLUDING A SITUATIONAL ANALYSIS AND A CORRECTIVE AND PREVENTIVE ACTION PLAN, IN ORDER TO GAIN ADDITIONAL INSIGHT INTO THIS ISSUE AND TO PREVENT ITS OCCURRENCE. CAPA IS ASSIGNED TO VM TEAM PR402679 AND INVESTIGATION IS UNDERGOING. SPIKE COMPONENT IS RECEIVED FROM VM AND FINAL ASSEMBLY IS DONE IN CAZIN PLANT. CT-SCAN IS SHOWING MOLDING ISSUE WITH THE SPIKE COMPONENT ATTACHMENT B. THE OPERATORS ARE NOW TRAINED TO OPEN NCR REGARDLESS OF PREVIOUS SHIFT OR PREVIOUS NCR-S RAISED AS LONG AS THE DEFECT IS DIFFERENT. VM TEAM IDENTIFIED THIS AS MAIN CAUSE OF THIS ISSUE. RE-TRAINING TO ALL INVOLVED PEOPLE TO CREATE SNC WHEN A FAILURE FOUND INDEPENDENTLY OF AN EXISTING ONE (0901-013-000-SWI NON-CONFORMING MATERIAL CONTROL) (MPS-18-1254-SA) SITUATION ANALYSES.
IT WAS REPORTED THAT A BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS NOT REGISTERED WITH THE FDA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182791 | BD PHASEAL ¿SECONDARY SET C61 WITH A BUILT-IN PHASEAL¿ CONNECTOR | ADMINISTRATION SET | LHI | BECTON DICKINSON | 1005467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |