COONS DILATOR
Report
- Report Number
- 1820334-2022-01294
- Event Type
- Malfunction
- Date Received
- July 28, 2022
- Report Date
- August 5, 2022
- Manufacturer
- COOK INC
- Product Code
- DRE
- UDI-DI
- 00827002044432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) #: K183036. 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.
D2A - ADDITIONAL COMMON NAME: FGE CATHETER, BILIARY, DIAGNOSTIC. D2B- ADDITIONAL PRODUCT CODE: FGE. . 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.
CORRECTION: H6 (ANNEX A). CORRECTION: DURING THE PRELIMINARY INVESTIGATION, THE DEVICE FAILURE ANALYSIS FOUND THAT ADHESIVE WAS PRESENT ON THE PACKAGING AND THE SEAL WAS, IN FACT NOT, ENTIRELY MISSING. DAMAGE TO PACKAGING WAS NOTICEABLE BY THE END USER. THE EVENT IS NOW NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY AND/OR PRODUCT MALFUNCTION. UPDATED REPORTS REGARDING THIS EVENT WILL NO LONGER BE PROVIDED. 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.
IT WAS REPORTED TO COOK THAT A COONS DILATOR ARRIVED TO THE CUSTOMER IN AN UNSEALED PACKAGE. THE DEVICE WAS UNUSED AND MADE NO PATIENT CONTACT. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 27JUL2022, THE CUSTOMER REPORTED THAT, "WE THINK IT MUST HAVE GOTTEN HOT IN THE TRUCK, THE SEAL WAS OPEN ON IT. THE ITEM ITSELF LOOKED FINE, WE JUST COULDN'T USE IT ON A PATIENT BECAUSE IT ARRIVED UNSEALED." THE COMPLAINT DEVICE WAS RECEIVED BY THE MANUFACTURER ON 01AUG2022. IT WAS NOTED DURING THE PRELIMINARY INVESTIGATION THAT ALTHOUGH THE CHEVRON AREA WAS OPEN, THERE WERE TRACES OF ADHESIVE FOUND ON THE CLEAR FILM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2941927 | COONS DILATOR | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | DRE | COOK INC | N/A | 14751242 | 00827002044432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |