FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
Report
- Report Number
- 1820334-2019-02020
- Event Type
- Malfunction
- Date Received
- August 15, 2019
- Date of Event
- August 8, 2019
- Report Date
- May 29, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002311206
- PMA / PMN Number
- K142819
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. DEVICE NOT CLEARED FOR SALE IN THE US. PRODUCT CODE OF SIMILAR DEVICE: DYB. G5: DEVICE NOT CLEARED FOR SALE IN THE US. 510(K)# OF SIMILAR DEVICE: K142819. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE UNUSED KSAW-6.0-38-90-RB-SHTL WAS RETURNED. THE VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED AN ADDITIONAL WHITE PIECE FROM AN UNKNOWN SOURCE IN THE BOTTOM OF THE PEEL POUCH OF THE PACKAGING. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT OTHERWISE MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DOCUMENTATION, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE DEVICE FAILURE WAS RELATED TO THE MANUFACTURING AND PACKAGING OF THE DEVICE. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PMA/510(K) NUMBER: PRE-AMENDMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, A CONTAMINANT WAS FOUND IN THE PACKAGE OF A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WHEN THE DEVICE WAS PULLED FROM STOCK. THE UNUSED DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691137 | FLEXOR SHUTTLE TIBIAL GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | 9685396 | 00827002311206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |