AS SYR PSD MICROBORE
Report
- Report Number
- 9616066-2020-02262
- Event Type
- Malfunction
- Date Received
- July 16, 2020
- Date of Event
- June 20, 2020
- Report Date
- July 10, 2020
- Manufacturer
- CFN MEXICO 215 SA DE CV
- Product Code
- FPA
- UDI-DI
- 07613203012430
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
CORRECTION: ADDITIONAL INFORMATION WAS PROVIDED. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.3. DATE OF EVENT: (B)(6) 2020. B.4. DATE EVENT REPORTED TO CFN: (B)(6) 2020. D.4. LOT #: 20015853. D.4. DEVICE EXPIRATION DATE: (B)(6) 2023. G4. AWARENESS DATE: (B)(6) 2020. H.4. DEVICE MANUFACTURE DATE: 01/10/2020.
ONE PHOTO OF THE CRACKED SYRINGE WAS RECEIVED BY THE QUALITY TEAM FOR EVALUATION. FROM THE PHOTO PROVIDED, IT WAS OBSERVED THAT THERE WAS A CRACK AT THE NEEDLE ADAPTER LOCATION OF THE SYRINGE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 WITH A LOT NUMBER OF 20015853 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS FOR WAS BUILT ON (B)(6) 2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THESE SETS. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE PRESSURE RATED EXT SET, IV CONNECTOR TUBE WAS FOUND DISCOLORED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THE TUBE WAS DISCOLORED BEFORE USE.
IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING HAD A CRACK IN THE CLAVE, AND BLOOD BACKED UP INTO THE MORPHINE SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " MORPHINE TUBING CRACKED AT CLAVE. BLOOD BACKED UP TO MORPHINE SYRINGE. TUBING DISCONNECTED STERILELY WITH 2 RNS. NEW TUBING RECONNECTED STERILELY. WHEN DID THE INCIDENT HAPPEN BEFORE USE , DURING USE OR AFTER USE AND ALSO THE DATE OF THE INCIDENT? DURING PRODUCT USE AND ADMINISTRATION OF IV FLUIDS. IF A PATIENT WAS INVOLVED ANY ADVERSE EFFECT ON THE PATIENT? NO ADVERSE EFFECT TO THE PATIENT OCCURRED AS A RESULT OF TUBING MALFUNCTION.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # [20015853] WAS NOT FOUND FOR THE REPORTED CATALOG # [2420-0500]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. . 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.
IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING HAD A CRACK IN THE CLAVE, AND BLOOD BACKED UP INTO THE MORPHINE SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " MORPHINE TUBING CRACKED AT CLAVE. BLOOD BACKED UP TO MORPHINE SYRINGE. TUBING DISCONNECTED STERILELY WITH 2 RNS. NEW TUBING RECONNECTED STERILELY. WHEN DID THE INCIDENT HAPPEN BEFORE USE , DURING USE OR AFTER USE AND ALSO THE DATE OF THE INCIDENT? DURING PRODUCT USE AND ADMINISTRATION OF IV FLUIDS. IF A PATIENT WAS INVOLVED ANY ADVERSE EFFECT ON THE PATIENT? NO ADVERSE EFFECT TO THE PATIENT OCCURRED AS A RESULT OF TUBING MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746808 | AS SYR PSD MICROBORE | INTRAVASCULAR ADMINISTRATION SET | FPA | CFN MEXICO 215 SA DE CV | 2420-0500 | 20015853 | 07613203012430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |