FDA Adverse Event
Malfunction
Summary report: N
C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW
MDR report key: 7088996
·
Received December 6, 2017
Report
- Report Number
- 1917413-2017-00430
- Event Type
- Malfunction
- Date Received
- December 6, 2017
- Date of Event
- January 6, 2017
- Report Date
- November 16, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JSM
- UDI-DI
- 00382903649532
- PMA / PMN Number
- K024240
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STERILITY BREACH WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #6182723 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STRAW OF 4.0 ML 13X75 MM PLASTIC C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW TORE THROUGH THE PACKAGE. NO INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865305 | C&S PRESERVATIVE TUBE AND URINE TRANSFER STRAW | URINE COLLECTION SET | JSM | BECTON, DICKINSON & CO. | 6182723 | 00382903649532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |