BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2019-01076
- Event Type
- Malfunction
- Date Received
- June 27, 2019
- Date of Event
- June 10, 2019
- Report Date
- August 2, 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
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 (B)(4) 1024879-2019-00960 (B)(4) 1024879-2019-00981 (B)(4) 1024879-2019-00975 (B)(4) 1024879-2019-00991 (B)(4) 1024879-2019-01005 (B)(4) 1024879-2019-00984 (B)(4) 1024879-2019-01038 (B)(4) 1024879-2019-01059 (B)(4) 1024879-2019-01071 (B)(4) 1024879-2019-01064 (B)(4) 1024879-2019-01094 (B)(4) 1024879-2019-01076 (B)(4) 1024879-2019-01107 (B)(4) 1024879-2019-01107 (B)(4) 1024879-2019-01091 (B)(4) 1024879-2019-01143 (B)(4) 1024879-2019-01130 (B)(4) 1024879-2019-01147 (B)(4) 1024879-2019-01157 (B)(4) 1024879-2019-01156 (B)(4) 1024879-2019-01163 (B)(4) 1024879-2019-01237 (B)(4) 1024879-2019-01195 (B)(4) 1024879-2019-01218 (B)(4) 1024879-2019-01116 (B)(4) 1024879-2019-01224 (B)(4) 1024879-2019-01197 (B)(4) 1024879-2019-01273 (B)(4) 1024879-2019-01304 (B)(4) 1024879-2019-01265 (B)(4) 1024879-2019-01303 (B)(4) 1024879-2019-01288 (B)(4) 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 (B)(4) 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).
INVESTIGATION SUMMARY: BD RECEIVED UNOPENED SAMPLES, ONE SAMPLE IN A PREVIOUSLY OPENED PACKAGE, AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SEPARATION OF THE DEVICE HOUSING WITH THE INCIDENT LOT WAS OBSERVED. VISUAL INSPECTION WAS CONDUCTED ON THE SAMPLE IN THE OPENED PACKAGE, AND A SPRING AND FRONT BARREL COMPONENT WERE OBSERVED. THE UNOPENED SAMPLES WERE TESTED FOR RETRACTION AND LOCKOUT, AND NO SEPARATION OR OTHER ISSUES WERE IDENTIFIED. 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. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS AND SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FRONT/REAR BARREL SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA #982194. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: CAPA #982194 HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. 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 AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.
IT WAS REPORTED THAT THE WINGSET CAME APART AFTER ENGAGING SAFETY, LEAVING NEEDLE EXPOSED WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THIS OCCURRED ON 6 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WINGSET CAME APART AFTER ENGAGING THE SAFETY DEVICE, LEAVING THE NEEDLE EXPOSED. ADDITIONAL INFORMATION BY INITIAL REPORTER: "368656 CAME APART AFTER ENGAGING THE SAFETY DEVICE. I HAVE HAD SEVERAL BATCHES OF NEEDLES THAT ARE BROKEN. I'LL USE THEM AND THEN THE BOTTOM PIECE COMES DETACHED CAUSING THE DIRTY NEEDLE TO BE EXPOSED WHEN YOU CLICK THE RELEASE BUTTON." "PUSH BUTTON WINGSET CAME APART AFTER ENGAGING THE PUSH BUTTON." NO PATIENT IDENTIFIERS ARE AVAILABLE.
IT WAS REPORTED THAT THE WINGSET CAME APART AFTER ENGAGING SAFETY, LEAVING NEEDLE EXPOSED WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THIS OCCURRED ON 6 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WINGSET CAME APART AFTER ENGAGING THE SAFETY DEVICE, LEAVING THE NEEDLE EXPOSED. ADDITIONAL INFORMATION BY INITIAL REPORTER: "368656 CAME APART AFTER ENGAGING THE SAFETY DEVICE. I HAVE HAD SEVERAL BATCHES OF NEEDLES THAT ARE BROKEN. I'LL USE THEM AND THEN THE BOTTOM PIECE COMES DETACHED CAUSING THE DIRTY NEEDLE TO BE EXPOSED WHEN YOU CLICK THE RELEASE BUTTON." "PUSH BUTTON WINGSET CAME APART AFTER ENGAGING THE PUSH BUTTON." NO PATIENT IDENTIFIERS ARE AVAILABLE.
MEDICAL DEVICE TYPE: JKA, FMI. (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE WINGSET CAME APART AFTER ENGAGING SAFETY, LEAVING NEEDLE EXPOSED WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THIS OCCURRED ON 6 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WINGSET CAME APART AFTER ENGAGING THE SAFETY DEVICE, LEAVING THE NEEDLE EXPOSED. ADDITIONAL INFORMATION BY INITIAL REPORTER: "368656 CAME APART AFTER ENGAGING THE SAFETY DEVICE. I HAVE HAD SEVERAL BATCHES OF NEEDLES THAT ARE BROKEN. I'LL USE THEM AND THEN THE BOTTOM PIECE COMES DETACHED CAUSING THE DIRTY NEEDLE TO BE EXPOSED WHEN YOU CLICK THE RELEASE BUTTON." "PUSH BUTTON WINGSET CAME APART AFTER ENGAGING THE PUSH BUTTON." NO PATIENT IDENTIFIERS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536032 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | FMI | BECTON, DICKINSON & CO., (BD) | 9091626 | 50382903686563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |