CONNECTA WHT 360DEG TB 100CM
Report
- Report Number
- 9610847-2021-00077
- Event Type
- Malfunction
- Date Received
- February 22, 2021
- Date of Event
- January 25, 2021
- Report Date
- July 13, 2021
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H6: INVESTIGATION SUMMARY A COMPLAINT OF FOREIGN MATTER WAS RECEIVED FROM THE CUSTOMER. A PHOTO WAS PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. IN THE PHOTO, FOREIGN MATTER CAN BE SEEN IN THE TUBING. THE CUSTOMER COMPLAINT WAS VERIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 394961 BECAUSE AN INVALID LOT NUMBER WAS PROVIDED BY THE CUSTOMER. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. D.4. MEDICAL DEVICE LOT #: 0183684. H.4. DEVICE MANUFACTURE DATE: 2020-07-31.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/28/2021. H.6. INVESTIGATION: A COMPLAINT OF FOREIGN MATTER WAS RECEIVED FROM THE CUSTOMER. A PHOTO WAS PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. IN THE PHOTO, FOREIGN MATTER CAN BE SEEN IN THE TUBING. THE CUSTOMER COMPLAINT WAS VERIFIED. A SAMPLE WAS ALSO PROVIDED FOR THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0183684. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THE FAILURE MODE PRESENTED IS CARBONIZED RESIN, THIS HAPPENS IN THE PROCESS OF EXTRUSION, THIS MATERIAL IS NOT PRODUCED IN OUR FACILITIES. IT IS ATTRIBUTED TO THE RAW MATERIAL PROVIDED BY THE SUPPLIER
IT WAS REPORTED THAT CONNECTA WHT 360DEG TB 100CM HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING AN OCULAR INSPECTION OF THE PRODUCT, A BROWN SUBSTANCE WAS IDENTIFIED INSIDE THE LINE. PICTURES AVAILABLE ACCORDING TO THE ORIGINAL COMPLAINANT. INFORMATION ABOUT POTENTIAL ADVERSE EVENTS MISSING.
IT WAS REPORTED THAT CONNECTA WHT 360DEG TB 100CM HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING AN OCULAR INSPECTION OF THE PRODUCT, A BROWN SUBSTANCE WAS IDENTIFIED INSIDE THE LINE. PICTURES AVAILABLE ACCORDING TO THE ORIGINAL COMPLAINANT. INFORMATION ABOUT POTENTIAL ADVERSE EVENTS MISSING.
IT WAS REPORTED THAT CONNECTA WHT 360DEG TB 100CM HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING AN OCULAR INSPECTION OF THE PRODUCT, A BROWN SUBSTANCE WAS IDENTIFIED INSIDE THE LINE. PICTURES AVAILABLE ACCORDING TO THE ORIGINAL COMPLAINANT. INFORMATION ABOUT POTENTIAL ADVERSE EVENTS MISSING.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
IT WAS REPORTED THAT CONNECTA WHT 360DEG TB 100CM HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING AN OCULAR INSPECTION OF THE PRODUCT, A BROWN SUBSTANCE WAS IDENTIFIED INSIDE THE LINE. PICTURES AVAILABLE ACCORDING TO THE ORIGINAL COMPLAINANT. INFORMATION ABOUT POTENTIAL ADVERSE EVENTS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260479 | CONNECTA WHT 360DEG TB 100CM | INTRAVASCULAR ADMINISTRATION SET | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 0183684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |