MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; ANESTHESIA CONDUCTION KIT

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:.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12891629
• MDR Text Key: 281429329
• Report Number: 12891629
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IPN046021
• Device Catalogue Number: FB-19608-SST
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6570 DA
• Patient Sex: Male