ARNDT ENDOBRONCHIAL BLOCKER SET
Report
- Report Number
- 1820334-2022-01759
- Event Type
- Malfunction
- Date Received
- November 22, 2022
- Date of Event
- November 14, 2022
- Report Date
- May 22, 2023
- Manufacturer
- COOK INC
- Product Code
- CBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4 - PMA/510(K) #: K160542. 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, UNAVAILABLE, OR UNCHANGED. CORRECTION: H6 - ANNEX G. INVESTIGATION ¿ EVALUATION: ON 15NOV2022, A REPRESENTATIVE OF FAIRFAX HOSPITAL (UNITED STATES) REPORTED TO COOK ABOUT AN ISSUE WITH AN ARNDT ENDOBRONCHIAL BLOCKER SET (C-AEBS-9.0-78-SPH-AS; LOT: 14340634). A HAIR-LIKE FIBER WAS NOTED IN THE PACKAGING. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT THE FAILURE WAS NOTED IN A STOCKROOM. THERE WAS NO PATIENT INVOLVEMENT IN THIS INCIDENT. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE SEALED C-AEBS-9.0-78-SPH-AS DEVICE WAS RETURNED TO COOK FOR EVALUATION. A PHYSICAL EXAMINATION OF THE DEVICE CONFIRMED A HAIR-LIKE FIBER IN THE SEALED PACKAGING. 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 14340634 REVEALED NO RELATED NON-CONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM LOT 14340634 AT THE TIME OF INVESTIGATION. EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, REVIEW OF THE DMR AND DHR SUGGESTS THERE ARE NO ADDITIONAL NONCONFORMING PRODUCTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT C_T_AEBS_REV6 IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: HOW SUPPLIED: ¿DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THE ROOT CAUSE OF THIS INCIDENT WAS A QUALITY CONTROL DEFICIENCY. FOREIGN MATTER WAS FOUND IN THE SEALED PACKAGING AND IS THEREFORE OUT OF SPECIFICATION. THERE ARE 100% INSPECTIONS IN PLACE FOR FOREIGN MATTER AND THERE IS NO EVIDENCE OF ADDITIONAL NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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.
INITIAL REPORTER OCCUPATION: UNKNOWN. 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.
IT WAS REPORTED IN ADDITIONAL INFORMATION ON 22NOV2022, THAT THE ISSUE WAS NOTED IN THE STOREROOM. IT WAS CONFIRMED THAT NO CONTACT WITH THE PATIENT WAS MADE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IT WAS REPORTED THAT A "HAIR" WAS FOUND INSIDE THE PACKAGING OF AN ARNDT ENDOBRONCHIAL BLOCKER SET. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2686302 | ARNDT ENDOBRONCHIAL BLOCKER SET | CBI TUBE, TRACHEAL/BRONCHIAL | CBI | COOK INC | N/A | 14340634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |