MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET
Report
- Report Number
- 1820334-2021-02469
- Event Type
- Injury
- Date Received
- November 10, 2021
- Date of Event
- October 12, 2021
- Report Date
- March 17, 2022
- Manufacturer
- COOK INC
- Product Code
- KNT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
OCCUPATION: CLINICAL PRODUCT SPECIALIST. PMA/510(K) #: K190084. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. AURORA MEDICAL CENTER SUMMIT (UNITED STATES) CONTACTED COOK STATING THAT, DURING A FEEDING TUBE PLACEMENT PROCEDURE FOR A 61-YEAR-OLD MALE PATIENT, THE HUB OF THE MRT-9.5-130 DEVICE FROM AN UNKNOWN LOT SEPARATED FROM THE TUBE. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE BODY AND NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE, WHICH WAS THE PLACEMENT OF ANOTHER FEEDING TUBE DEVICE. REVIEWS OF THE DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE RETURNED PRODUCT NOTED HUB DETACHMENT APPROXIMATELY 1CM FROM THE HUB. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT THERE ARE PROCESSES DURING MANUFACTURING TO CHECK FOR AND PREVENT NONCONFORMING PRODUCT FROM LEAVING HOUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED DUE TO THE LACK OF LOT INFORMATION FROM THE FACILITY. A REVIEW OF SALES TO THE FACILITY OVER THE LAST THREE YEARS WAS COMPLETED; HOWEVER, IT WAS NOT POSSIBLE TO NARROW DOWN A LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE CONTRIBUTED TO THE REPORTED FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A SMALL BORE FEEDING TUBE PLACEMENT PROCEDURE IN WHICH THE MCCLEAN-RING NASOJEJUNAL FEEDING TUBE SET WAS USED. WHEN THE PRIMARY NURSE STARTED TUBE FEEDING, THE TUBE SNAPPED BELOW THE HUB. THE PATIENT THEN RETURNED TO INTERVENTIONAL RADIOLOGY TO HAVE THE TUBE REMOVED AND REPLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. NO OTHER ADVERSE EFFECTS WERE REPORTED.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1684815 | MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET | KNT TUBES, GASTROINTESTINAL | KNT | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention |