PERFORMER INTRODUCER
Report
- Report Number
- 1820334-2022-01688
- Event Type
- Malfunction
- Date Received
- November 4, 2022
- Report Date
- February 7, 2023
- Manufacturer
- COOK INC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. INITIAL REPORTER OCCUPATION: CLINICAL SUPPLY CHAIN ASSISTANT MANAGER. RPN: BASED ON THE DESCRIPTION OF THE DEVICE AS A 14 FRENCH CHECK-FLO, POSSIBLE RPNS INCLUDE RCFW-14.0-38-30-RB, RCFW-14.0-38-45-RB, RCFW-14.0-38-63-RB-MTS, RCFW-14.0-38-75-RB-MTS, RCFW-14.0-38-80-RB, RCFW-14.0-38-85-RB-MTS. PMA/510(K) NUMBER: BASED ON THE DESCRIPTION OF THE DEVICE AS A 14 FRENCH CHECK-FLO, THE 510(K) IS BELIEVED TO BE K171999 OR K171988. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5, D1, D4, G4 G4: K171999 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: D9, H3: THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. CORRECTED INFORMATION: H4, H5: "YES" SUMMARY OF EVENT: AS REPORTED, UPON OPENING A PERFORMER INTRODUCER, A SHARP PORTION WAS NOTED AT THE DISTAL TIP. THE INTRODUCER WAS USED AND REMOVED WITHOUT INCIDENT. THERE HAS BEEN NO REPORT OF PATIENT INJURY. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. ONE RELEVANT NON-CONFORMANCE WAS NOTED ON A SUBASSEMBLY LOT; HOWEVER, ALL AFFECTED PRODUCT WAS SCRAPPED AND THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THE NON-CONFORMANCE. THE PRODUCT IFU INSTRUCTS THE USER TO INSPECT THE PRODUCT UPON REMOVAL FROM THE PACKAGE TO ENSURE NO DAMAGE HAS OCCURRED. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO THE DESIGN OR MANUFACTURING OF THE COMPLAINT DEVICE CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
AS REPORTED, UPON OPENING AN UNSPECIFIED 14 FRENCH CHECK-FLO INTRODUCER, A SHARP PORTION WAS NOTED AT THE DISTAL TIP. THE INTRODUCER WAS USED AND REMOVED WITHOUT INCIDENT. THERE HAS BEEN NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
ADDITIONAL INFORMATION WAS RECEIVED 10NOV2022. THE DEVICE WAS A PERFORMER INTRODUCER.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2798554 | PERFORMER INTRODUCER | DYB INTRODUCER, CATHETER | DYB | COOK INC | G08957 | 14846198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |