BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.)
Report
- Report Number
- 2243072-2021-02933
- Event Type
- Malfunction
- Date Received
- December 17, 2021
- Date of Event
- November 19, 2021
- Report Date
- June 1, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- KDT
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4) US FOUR OAKS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 27-DEC-2021. H.6. INVESTIGATION: THIS STATEMENT SERVES TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT ON PRODUCT 220115 (CULTURESWAB STERILE SINGLE SWAB), LOT NUMBER 2013969, WHERE IT WAS OBSERVED THAT THE TUBE HAD A HOLE IN IT. EVENT DESCRIPTION: " DAMAGE TO THE PLASTIC SHAFT CONTAINING THE SWABS WERE IDENTIFIED WHEN PROCESSED IN THE LAB. 2 HOLES VISIBLE . PROCESSING THE SWAB REQUIRES LIQUID MEDIA TO BE ADDED TO THE DRY SWAB WHEN RECEIVED IN A BIOLOGICAL SAFETY CABINET WHICH SQUIRTS OUT OF THE PLASTIC SHAFT CONTAINING THE SWAB AND MEDIA DURING PROCESSING. THIS HAS RESULTED IN AN INCIDENT WHEREBY LIQUID MEDIA HAS SQUIRTED ON TO S STAFF MEMBERS COAT¿ COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: THE RETURNS WERE INSPECTED, AND NO HOLES WERE FOUND. THE RETENTION SAMPLES DID NOT EXHIBIT ANY DEFECTS. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE RETURN SAMPLES WERE SATISFACTORY AND DID NOT HAVE THE NOTED DEFECT. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION AND THE RETENTION SAMPLES WERE SATISFACTORY, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED ON THE RETURNS. THIS PRODUCT IS A DRY SWAB WITH NO MEDIA IN IT. ADDITIONALLY, THE ADDITION OF MEDIA TO THIS TUBE IS NOT COVERED IN THE PRODUCT INSERT AND ANY PROCESSING OF THE SWAB NOT COVERED IN THE INSERT NEEDS TO BE VALIDATED BY THE CUSTOMER. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. BD WILL CONTINUE TO MONITOR FOR TRENDING.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4) US FOUR OAKS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.) A SPLASH OF REAGENT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " POSSIBLE DEFECT IN THE STUBE WHICH IS RESULTING IN LEAKING IS NOT VISIBLE PRIOR TO ADDITION OF THE LIQUID MEDIA. "
IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.) A SPLASH OF REAGENT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " POSSIBLE DEFECT IN THE STUBE WHICH IS RESULTING IN LEAKING IS NOT VISIBLE PRIOR TO ADDITION OF THE LIQUID MEDIA. "
IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.) A SPLASH OF REAGENT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " POSSIBLE DEFECT IN THE STUBE WHICH IS RESULTING IN LEAKING IS NOT VISIBLE PRIOR TO ADDITION OF THE LIQUID MEDIA. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1925693 | BD BBL¿ CULTURESWAB¿, STERILE, SINGLE SWAB (100 PKG.) | CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE | KDT | BECTON DICKINSON | 2013969 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |