TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR
Report
- Report Number
- 3003916417-2021-00186
- Event Type
- Malfunction
- Date Received
- July 27, 2021
- Date of Event
- June 22, 2021
- Report Date
- October 26, 2021
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO ERRONEOUS RESULTS/STOPPER ISSUE WERE OBSERVED. 195 SAMPLES FROM EACH BATCH WERE VISUALLY EVALUATED. FOR STOPPER FUNCTION THE PRODUCT WAS EVALUATED TO SEE IF THERE WERE NO STOPPER LOOSE AND THE PRODUCT WAS PROPERLY CAPPED. FOR ERRONEOUS RESULTS THE PRODUCT WAS EVALUATED TO VERIFY IF THERE WOULD BE ANY ADDITIVE ABNORMALITY (SPRAY PATTERN OR ADDITIVE COLOR VARIATION) AND THE PRODUCT WAS ACCORDING SPECIFICATION. FOR DIFFICULT TO INSERT STOPPERS NO TEST WAS EXECUTED SINCE THERE IS NO REQUIREMENT OR ACCEPTANCE CRITERIA TO BE EVALUATED BASED ON BD SPECIFICATIONS. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS/STOPPER ISSUE) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. THERE WERE NO STOPPER ISSUES NOTED. LABORATORY ANALYSIS OF RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. THE EDTA TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THE BATCH HISTORY REVIEW FOR BATCH 1051669 WAS SATISFACTORY PER INTERNAL PROCEDURES. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE ERRONEOUS RESULTS/STOPPER ISSUE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS/STOPPER ISSUE WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED WHEN USING THE TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR, THE DEVICE EXPERIENCED STOPPER PULL OUT OF TUBE WHEN IN AN ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: STOPPERS OF BATCH 0344058 ARE POPPING OFF IN CENTRIFUGE, AND SEVERAL OF THEM ARE POPPING OF AFTER SAMPLE DRAW BY NURSE, CAUSING A LEAKAGE.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR, THE DEVICE EXPERIENCED STOPPER PULL OUT OF TUBE WHEN IN AN ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: STOPPERS OF BATCH 0344058 ARE POPPING OFF IN CENTRIFUGE, AND SEVERAL OF THEM ARE POPPING OF AFTER SAMPLE DRAW BY NURSE, CAUSING A LEAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1132769 | TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | 0344058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |