MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
Report
- Report Number
- 1820334-2020-00074
- Event Type
- Malfunction
- Date Received
- January 7, 2020
- Report Date
- August 12, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002480049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ON 02JAN2020 COOK WAS INFORMED OF A COMPLAINT ON A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. IT WAS REPORTED THAT AFTER REMOVAL FROM THE PRODUCT PACKAGING, THE HUB BROKE OFF THE INTRODUCER. AS A RESULT, THE DEVICE WAS NOT USED, THE DEVICE DID NOT MAKE PATIENT CONTACT. THE DEVICE WAS DISCARDED AT THE HOSPITAL AND IS NOT AVAILABLE FOR RETURN. INVESTIGATION EVALUATION: A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS MADE OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. 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. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. SUPPLIER INVESTIGATION. THE OUTER CATHETER AND HUB ARE MANUFACTURED AND BONDED TOGETHER AT AN APPROVED VENDOR. COOK REQUESTED THAT THE SUPPLIER INVESTIGATE THIS OCCURRENCE. THE SUPPLIER CONCLUDED THAT THERE IS NO EVIDENCE TO SUPPORT MANUFACTURING ISSUES WERE THE CAUSE OF THIS FAILURE. THE COMPLETE SUPPLIER INVESTIGATION IS ATTACHED TO THE COMPLAINT FILE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. WITH CURRENT INFORMATION THE CAUSE FOR THIS COMPLAINT COULD NOT BE ESTABLISHED. HOWEVER, THERE WAS NO EVIDENCE UNCOVERED DURING THE INVESTIGATION TO SUGGEST THAT MANUFACTURING ISSUES WERE THE CAUSE OF THIS COMPLAINT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.
D10 & H3: CUSTOMER HAS INFORMED US THAT THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. 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 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.
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K171275. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, PRIOR TO PATIENT CONTACT, THE HUB SEPARATED FROM A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. THE COMPLAINT DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19334 | MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G48004 | 10133897 | 00827002480049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |