ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
Received Oct 7, 2024 · Event occurred Jul 16, 2024
Report 2025851-2024-00009 · MDR key 20384302
Device
Generic name
Gastrostomy Tube
Manufacturer
Xeridiem Medical DevicesModel number
UNKNOWNCatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Unintended Movement
- Unintended Movement
Patient
NA · Prefer Not To Disclose
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WE TOOK BACK TO THE OPERATING ROOM A PATIENT WHO HAD HAD A PERCUTANEOUS GASTROSTOMY TUBE INSERTED (WITH ANCHORS) ON (B)(6) 2024 BECAUSE IT HAD MOVED. THIS PROBLEM HAD ALREADY OCCURRED RECENTLY WITH OTHER PATIENTS.
Additional Manufacturer Narrative
A1-A6) THERE WAS NO PATIENT INFORMATION AVAILABLE FROM THIS EVENT. D4) MODEL AND CATALOG NUMBERS ARE NOT KNOWN BUT ARE DISTRIBUTED BY COOK MEDICAL. EXPIRATION DATE AND FULL UDI IS UNKNOWN SINCE LOT NUMBER IS UNKNOWN. E1) INITIAL REPORTER ASSOCIATED WITH COOK MEDICAL COMPLAINT HANDLING GROUP FOR EUROPE. EVENT OCCURRED AT C.H.U TOULOUSE IN FRANCE. H3) AS OF FILING OF THIS EMDR, THE INVOLVED DEVICE HAS NOT YET BEEN RECEIVED ALTHOUGH ITS RETURN IS REQUESTED. H6) CODES CHOSEN BASED ON INFORMATION REPORTED IN THE COMPLAINT AND INVESTIGATION BEING IN PROCESS. INTERNAL COMPLAINT NUMBER (B)(4). XERIDIEM MEDICAL DEVICES HAD REQUESTED FROM THE DISTRIBUTOR ADDITIONAL INFORMATION ABOUT THE INCIDENT AS WELL AS RETURN OF THE DEVICE FOR EVALUATION (INCLUDING A TRACKING NUMBER FOR THE RETURN). THE DEVICE WAS RECEIVED ON 10/23/2024. HOWEVER, DEVICE WAS CONFIRMED TO NOT BE MANUFACTURED BY XERIDIEM. MULTIPLE FOLLOW-UP REQUESTS WERE SENT FOR MORE INFORMATION BUT NO RESPONSE. SO WE CONCLUDE THIS AS A NON-REPORTABLE BECAUSE THE DEVICE WAS NOT MANUFACTURED BY XERIDIEM MEDICAL DEVICES.
Description of Event or Problem
WE TOOK BACK TO THE OPERATING ROOM A PATIENT WHO HAD A PERCUTANEOUS GASTROSTOMY TUBE INSERTED (WITH ANCHORS) ON (B)(6) 2024 BECAUSE IT HAD MOVED. THIS PROBLEM HAD ALREADY OCCURRED RECENTLY WITH OTHER PATIENTS.
Additional Manufacturer Narrative
A1-A6) THERE WAS NO PATIENT INFORMATION AVAILABLE FROM THIS EVENT. D4) MODEL AND CATALOG NUMBERS ARE NOT KNOWN BUT ARE DISTRIBUTED BY COOK MEDICAL. EXPIRATION DATE AND FULL UDI IS UNKNOWN SINCE LOT NUMBER IS UNKNOWN. E1) INITIAL REPORTER ASSOCIATED WITH COOK MEDICAL COMPLAINT HANDLING GROUP FOR EUROPE. EVENT OCCURRED AT (B)(6). H3) AS OF FILING OF THIS EMDR, THE INVOLVED DEVICE HAS NOT YET BEEN RECEIVED ALTHOUGH ITS RETURN IS REQUESTED. H6) CODES CHOSEN BASED ON INFORMATION REPORTED IN THE COMPLAINT AND INVESTIGATION BEING IN PROCESS. INTERNAL COMPLAINT NUMBER (B)(4).