BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Report
- Report Number
- 1024879-2019-01143
- Event Type
- Malfunction
- Date Received
- July 9, 2019
- Date of Event
- June 15, 2019
- Report Date
- August 2, 2019
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- 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
- IL, 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: 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 # PAS-19-1567.
INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. BASED ON EVALUATION OF THE PHOTOS, FRONT/REAR BARREL SEPARATION WAS OBSERVED. THE SAMPLES WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR BARREL SEPARATION WITH THE INCIDENT LOT WAS NOT 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. 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, THE CUSTOMER¿S INDICATED FAILURE MODE 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 BARRELS OF 6 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH THE PRE-ATTACHED HOLDER BROKE APART FROM THE HUB DURING USE WHILE RETRACTING THE NEEDLE AND AFTER THE VENIPUNCTURE PROCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE APPROXIMATELY SIX OCCURRENCES OF THE BARREL BREAKING APART DURING THE RETRACTION PROCESS FOLLOWING THE VENIPUNCTURE PROCESS. APPROXIMATELY THREE DIFFERENT PHLEBOTOMISTS EXPERIENCED THIS ISSUE."
IT WAS REPORTED THAT THE BARRELS OF 6 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH THE PRE-ATTACHED HOLDER BROKE APART FROM THE HUB DURING USE WHILE RETRACTING THE NEEDLE AND AFTER THE VENIPUNCTURE PROCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE APPROXIMATELY SIX OCCURRENCES OF THE BARREL BREAKING APART DURING THE RETRACTION PROCESS FOLLOWING THE VENIPUNCTURE PROCESS. APPROXIMATELY THREE DIFFERENT PHLEBOTOMISTS EXPERIENCED THIS ISSUE."
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMI. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BARRELS OF 6 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH THE PRE-ATTACHED HOLDER BROKE APART FROM THE HUB DURING USE WHILE RETRACTING THE NEEDLE AND AFTER THE VENIPUNCTURE PROCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE APPROXIMATELY SIX OCCURRENCES OF THE BARREL BREAKING APART DURING THE RETRACTION PROCESS FOLLOWING THE VENIPUNCTURE PROCESS. APPROXIMATELY THREE DIFFERENT PHLEBOTOMISTS EXPERIENCED THIS ISSUE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564364 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 9091626 | 50382903686563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |