BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2019-01265
- Event Type
- Malfunction
- Date Received
- July 26, 2019
- Date of Event
- June 24, 2019
- Report Date
- August 22, 2019
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 50382903686563
- PMA / PMN Number
- K011984
- Removal / Correction Number
- PAS-19-1567
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: INVESTIGATION SUMMARY: AS OF AUGUST 2, 2019 THIS COMPLAINT IS UNDER THE SCOPE OF FIELD ACTION # PAS-19-1567: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SEPARATION OF THE FRONT AND REAR BARREL COMPONENTS WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#982194 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SEPARATION OF THE FRONT AND REAR BARREL COMPONENTS WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH CAPA#982194 AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: CAPA#982194 WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.
H.6. ADDITIONAL INFORMATION: THIS INFORMATION IS ASSOCIATED WITH FIELD ACTION # 2243072-07/22/2019-009-R. 1. RECALL SUMMARY BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR CERTAIN LOTS OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, CATALOG# 368656. BD HAS CONFIRMED THAT THESE LOTS MAY EXHIBIT SEPARATION OF FRONT AND REAR BARRELS UPON ACTIVATION OF THE SAFETY FEATURE THAT RETRACTS THE NEEDLE. 2. PRODUCT AND SCOPE BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, CATALOG NUMBER 368356, FOR THE FOLLOWING 12 LOTS: 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 LOTS NOT INCLUDED IN THE SCOPE OF THE RECALL ARE NOT AFFECTED. 3. DESCRIPTION OF ISSUE BD HAS CONFIRMED THAT THESE LOTS MAY EXHIBIT SEPARATION OF FRONT AND REAR BARRELS UPON ACTIVATION OF THE SAFETY FEATURE THAT RETRACTS THE NEEDLE. BARREL SEPARATION MAY RESULT IN LEAKAGE OF BLOOD OR AN EXPOSED NEEDLE, POTENTIALLY RESULTING IN EXPOSURE TO BLOOD BORNE PATHOGENS. BD PAS IDENTIFIED THIS ISSUE THRU THE BD COMPLAINT INVESTIGATION SYSTEM. 4. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE PER 806 # 2243072-07/22/2019-009-R DATED AUGUST 2, 2019, THERE WERE A TOTAL OF 33 COMPLAINTS AND 31 MDRS WITHIN SCOPE. COMPLAINT MDR 962379 1024879-2019-00960 965725 1024879-2019-00981 965727 1024879-2019-00975 972931 1024879-2019-00991 981188 1024879-2019-01005 986062 1024879-2019-00984 989400 1024879-2019-01038 993698 1024879-2019-01059 998331 1024879-2019-01071 1000056 1024879-2019-01064 1002704 1024879-2019-01094 1005676 1024879-2019-01076 1010746 1024879-2019-01107 1010746 1024879-2019-01107 1013450 1024879-2019-01091 1019617 1024879-2019-01143 1021032 1024879-2019-01130 1023362 1024879-2019-01147 1024787 1024879-2019-01157 1028776 1024879-2019-01156 1030289 1024879-2019-01163 1034707 1024879-2019-01237 1035616 1024879-2019-01195 1041239 1024879-2019-01218 1041257 1024879-2019-01116 1041265 1024879-2019-01224 1041273 1024879-2019-01197 1056870 1024879-2019-01273 1057014 1024879-2019-01304 1058286 1024879-2019-01265 1058303 1024879-2019-01303 1058337 1024879-2019-01288 1058337 1024879-2019-01288 5. HHE SUMMARY THE HHE CONSIDERED THE POTENTIAL HAZARDS, HARMS, SEVERITIES, AND LIKELIHOOD OF OCCURRENCE RELATED TO THE PRODUCT, SPECIFICALLY THE REPORTED ISSUE REGARDING THE SAFETY MECHANISM NOT FUNCTIONING AS INTENDED. EXPOSURE TO BLOOD, INCLUDING BLOODBORNE PATHOGENS REPRESENTS A POTENTIAL FOR IMMEDIATE AND LONG-TERM HEALTH CONSEQUENCE TO THE HEALTHCARE WORKER. THIS WOULD BE IN THE PRESENCE OF A NEEDLESTICK INJURY TO THE HCW AFTER THE DEVICE WAS USED ON A PATIENT AS WELL AS BLOOD LEAKAGE FROM THE DEVICE WHICH COULD COME IN DIRECT CONTACT WITH THE UNPROTECTED SKIN (NOT FOLLOWING PROPER PPE PROCEDURE) OF THE HCW COLLECTING THE BLOOD. THE LIKELIHOOD OF HEALTH RISK FROM THE USAGE OF UNNECESSARY POST-EXPOSURE PROPHYLAXIS (PEP) AND LABORATORY TESTING DUE TO CONTAMINATED NEEDLE STICK INJURY OR EXPOSURE OF NON-INTACT SKIN IS CONSIDERED MINIMAL. THIS IS SUPPORTED BY DOCUMENTED LITERATURE THAT INDICATES GOOD EFFICACY OF PEP BEING OBSERVED WITH NO SEROCONVERSION. GENERAL AWARENESS FOR THE USE OF SHARPS AS WELL AS THE USE OF GENERAL SAFETY PRECAUTIONS IS KNOWN TO HELP DECREASE THE LIKELIHOOD OF EXPOSURE TO BLOODBORNE PATHOGENS. 6. INVESTIGATION SUMMARY ROOT CAUSE INVESTIGATION INDICATES A MIS-ALIGNMENT OF TOOLING TO LOAD AND ASSEMBLE COMPONENTS IN THE ASSEMBLY LINE. BD PAS HAS INITIATED CAPA 982194 TO FURTHER INVESTIGATE THIS ISSUE, AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. 7. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z# PLEASE REFERENCE BD RECALL # (B)(4.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE REST OF THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WINGSET SEPARATES. 2 OF 4 COMPLAINTS OPENED FOR THE EXTRA DATES. WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE REST OF THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WINGSET SEPARATES. (B)(4) OF(B)(4) COMPLAINTS OPENED FOR THE EXTRA DATES. WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: JKA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE REST OF THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WINGSET SEPARATES. 2 OF 4 COMPLAINTS OPENED FOR THE EXTRA DATES. WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623813 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | FMI | BECTON, DICKINSON & CO., (BD) | 9086812 | 50382903686563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |