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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP ARGYLE PERITONEAL DIALYSIS CATHETER KIT; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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COVIDIEN LP ARGYLE PERITONEAL DIALYSIS CATHETER KIT; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Model Number 8817278006
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
Event Type  malfunction  
Event Description
Nurse opened the peritoneal dialysis catheter kit to the sterile field.Surgeon went to use the needle in the kit, and it broke off at the base as the surgeon went to put it into the skin.The problem was identified, and the device was taken off the field.Next, the introducer was being used and the side clip broke off.The problem was identified, and the device was taken off the field.At that time, the nurse called the supplies supervisor, and they came in to look at the device.It was removed from the room and a different one was opened to the field.
 
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Brand Name
ARGYLE PERITONEAL DIALYSIS CATHETER KIT
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key14955678
MDR Text Key295495931
Report Number14955678
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8817278006
Device Catalogue Number8817278006
Device Lot Number2014900191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2022
Event Location Hospital
Date Report to Manufacturer07/08/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/08/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18980 DA
Patient SexFemale
Patient Weight91 KG
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