GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER
Report
- Report Number
- 1820334-2024-00940
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Date of Event
- June 17, 2024
- Report Date
- August 27, 2024
- Manufacturer
- COOK INC
- Product Code
- MQF
- UDI-DI
- 00827002347830
- PMA / PMN Number
- K173686
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. CORRECTION: B3, D4, D9, H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
INVESTIGATION-EVALUATION: IT WAS REPORTED THE 'GUARDIA ACCESS EMBRYO TRANSFER CATHETERS' PACKAGING CONTAINED FOREIGN MATTER UPON OPENING, PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION, IN INNER POUCHES WITH NO ORIGINAL OUTER PACKAGING. SMALL BLACK PIECE OF PLASTIC IN OPENED INNER POUCH OF TRANSFER CATHETER. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THERE WERE NONCONFORMANCES RELATED TO DEBRIS/DEFECTS INSIDE AND EMBEDDED INTO THE DEVICE MATERIAL. THE AFFECTED DEVICES IN THE LOT WERE IDENTIFIED AND SCRAPPED OR REWORKED PRIOR TO DISTRIBUTION. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. THE INFORMATION PROVIDED UPON REVIEW OF THE DEVICE MASTER RECORD (DMR) AND DHR SUGGESTS THAT THERE IS EVIDENCE THE DEVICE LOT WAS MANUFACTURED OUT OF SPECIFICATION. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING; THE IFU "EMBRYO TRANSFER CATHETER," T_K-J-ETC2_REV1, INCLUDES THE FOLLOWING RELATED TO THE FAILURE MODE: "HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE STORE IN A DARK, DRY, COOL PLACE AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A MANUFACTURING EVENT LIKELY CONTRIBUTED TO THIS INCIDENT. DEFECT AWARENESS TRAINING WAS ISSUED FOR THE PERSONNEL RESPONSIBLE FOR THE MANUFACTURE OF AN OUT OF SPECIFICATION DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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 OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
IT WAS REPORTED THE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER'S PACKAGING CONTAINED FOREIGN MATTER UPON OPENING, PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2426461 | GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER | MQF CATHETER, ASSISTED REPRODUCTION | MQF | COOK INC | G34783 | 15634433 | 00827002347830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |