BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2019-01273
- Event Type
- Malfunction
- Date Received
- July 29, 2019
- Date of Event
- July 11, 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. ADDITIONAL INFORMATION: THIS INFORMATION IS ASSOCIATED WITH FIELD ACTION # 2243072-07/22/2019-009-R. 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. 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. 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. 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: (B)(4), MDR: 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. 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. 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. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z#: PLEASE REFERENCE BD RECALL # PAS-19-1567.
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 OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, 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: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA#: 982194. THE CAPA 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.
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. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WING SET FELL APART AT THE HUB. ANOTHER LOT NUMBER DOING THE SAME AS BEFORE. THE WING-SET FALLING APART AT THE HUB.
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. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WING SET FELL APART AT THE HUB. ANOTHER LOT NUMBER DOING THE SAME AS BEFORE. THE WING-SET FALLING APART AT THE HUB.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WING SET FELL APART AT THE HUB. ANOTHER LOT NUMBER DOING THE SAME AS BEFORE. THE WING-SET FALLING APART AT THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633060 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | FMI | BECTON, DICKINSON & CO., (BD) | 9091607 | 50382903686563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |