BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR
Report
- Report Number
- 2243072-2023-00055
- Event Type
- Malfunction
- Date Received
- January 24, 2023
- Date of Event
- January 11, 2023
- Report Date
- March 7, 2023
- 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
THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WERE ISSUES WITH BHCG TEST RESULTS WHEN USING THE ANALYZER OF ANOTHER COMPANY. WHEN THE COMPANY WAS CONTACTED TO PROVIDE A RESPONSE REGARDING THE RESULTS, IT WAS REPORTED THAT THE ISSUE WAS IN REGARD TO THE BD TUBES." D2: COMMON DEVICE NAME: BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. D2: MEDICAL DEVICE TYPE: JKA. D.3 MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON IND. CIRURGICAS LTDA. D.4. UNIQUE IDENTIFIER (UDI) #:(B)(4). G.1. MANUFACTURING LOCATION: BECTON DICKINSON IND. CIRURGICAS LTDA.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WERE ISSUES WITH BHCG TEST RESULTS WHEN USING THE ANALYZER OF ANOTHER COMPANY. WHEN THE COMPANY WAS CONTACTED TO PROVIDE A RESPONSE REGARDING THE RESULTS, IT WAS REPORTED THAT THE ISSUE WAS IN REGARD TO THE BD TUBES."
IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER TUBE THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WERE ISSUES WITH BHCG TEST RESULTS WHEN USING THE ANALYZER OF ANOTHER COMPANY. WHEN THE COMPANY WAS CONTACTED TO PROVIDE A RESPONSE REGARDING THE RESULTS, IT WAS REPORTED THAT THE ISSUE WAS IN REGARD TO THE BD TUBES."
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WERE ISSUES WITH BHCG TEST RESULTS WHEN USING THE ANALYZER OF ANOTHER COMPANY. WHEN THE COMPANY WAS CONTACTED TO PROVIDE A RESPONSE REGARDING THE RESULTS, IT WAS REPORTED THAT THE ISSUE WAS IN REGARD TO THE BD TUBES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389625 | BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |