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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT

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TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN046021
Device Problems Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Patient Problem Failure of Implant (1924)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
Situation: home nerve catheter broke while parent was attempting removal over telehealth visit, possibly with retained catheter piece in patient. Background: dressing removal was uneventful, the catheter was seen sliding out of the patient with what appeared to be minimal resistance. When the mother reached the end of the catheter, she stated that she was meeting resistance, and that it had been a little hard the whole time and now very hard. The patient was instructed to change positions to try to relax his abdominal muscles, massage the area around the catheter, sit up, stand up, take a deep breath in and out with no further movement of the catheter. Finally, it was suggested that the patient remove his shorts, as he was engaging his muscles in order to bend over and push them down. At this point his mother turned the camera around to preserve his privacy, had the patient lay down, and attempted to remove the catheter. The catheter snapped while the patient's mother was attempting to remove it, and there was no black tip at the end of the catheter. No catheter parts visible at insertion site. Assessment: the patient's surgeon was informed, and a plan was made for x-ray and ultrasound imaging the following morning. The ultrasound x-ray did not show evidence of a foreign body. Recommendation:.
 
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Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key12891629
MDR Text Key281429329
Report Number12891629
Device Sequence Number1
Product Code CAZ
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 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN046021
Device Catalogue NumberFB-19608-SST
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/05/2021
Event Location Hospital
Date Report to Manufacturer11/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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