YUEH CENTESIS DISPOSABLE CATHETER NEEDLE
Report
- Report Number
- 1820334-2021-01583
- Event Type
- Malfunction
- Date Received
- June 23, 2021
- Date of Event
- June 11, 2021
- Report Date
- December 10, 2021
- Manufacturer
- COOK INC
- Product Code
- GCB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON FURTHER INVESTIGATION, THIS EVENT IS NOT REPORTABLE. THERE IS NO INFORMATION CONFIRMING REPORTABLE DEVICE MALFUNCTION OR SERIOUS INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE FRACTURED DEVICE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. A REVIEW OF RISK DOCUMENTATION DOES NOT INDICATE THAT THIS EVENT IS LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO FRACTURE OF THE WHITE HUB, AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, PER 21CFR PART 803.50 THE COMPLAINT EVENT IS CONSIDERED NOT REPORTABLE. NO FOLLOW UP INFORMATION WILL BE SUBMITTED FOR THIS REPORT.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: B3, B5. 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.
G4 ¿ PMA/510(K) #: EXEMPT. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. CORRECTION: B5, D9, H3, H6- ANNEXES E AND F. 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.
ON (B)(6) 2021, IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS PERFORMING THE THORACENTESIS PROCEDURE, AS THEY BEGAN TO PERFORM SUCTIONING, IT WAS NOTICED THAT THE "CONNECTION WAS SUCKING AIR". THE DEVICE WAS THEN DISCOVERED TO HAVE FRACTURED AT THE HUB. THE PROCEDURE WAS LATER COMPLETED SUCCESSFULLY WITHOUT ISSUE. AN X-RAY TAKEN FOLLOWING THE PROCEDURE CONFIRMED THAT THE PATIENT DID NOT HAVE A PNEUMOTHORAX. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
IN ADDITIONAL INFORMATION RECEIVED 12JUL2021 IT WAS REPORTED THAT NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING TO THE TARGET LOCATION. DEVICE RETURN REVEALED THAT THE HUB OF THE CATHETER WAS FRACTURED, BUT NOT COMPLETELY SEPARATED.
IN ADDITIONAL INFORMATION RECEIVED ON 29JUN2021, IT WAS REPORTED THAT AS A RESULT OF THE BROKEN NEEDLE, THE PROCEDURE WAS PERFORMED ON ANOTHER DAY WITH A NEW LIKE DEVICE. NO ADDITIONAL INTERVENTION WAS REQUIRED. IT WAS ALSO CLARIFIED BY THE PHYSICIAN THAT NO BLEEDING COMPLICATIONS OCCURRED.
(B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT AN UNKNOWN COOK YUEH CATHETER NEEDLE BROKE DURING A DRAINAGE PROCEDURE. AS A RESULT, UNSPECIFIED BLEEDING COMPLICATIONS OCCURRED. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE AND THE PATIENT WAS REPORTED TO BE "OKAY". ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 952075 | YUEH CENTESIS DISPOSABLE CATHETER NEEDLE | GCB NEEDLE, CATHETER | GCB | COOK INC | 13784161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |