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

Model Number IPN045585

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  Injury  

Event Description

The patient was admitted for left shoulder arthroscopy with debridement of synovitis, rotator cuff repair and bicep tendonitis.A peripheral nerve catheter was placed by an anesthesia provider using ultrasound guidance.The patient was discharged with the catheter in place, which was connected to a disposable on-q pain pump.The patient had daily follow up with anesthesia providers to assess pain status.The patient was directed to remove the catheter with the help of her husband while the anesthesia provider was on the phone.The patient's husband was able to withdraw the catheter approximately 4 cm before encountering resistance.The patient was then directed to her local emergency department for catheter removal.The emergency room (er) medical doctor (md) was able to remove the catheter, but in doing so the catheter cover sheared off the internal catheter wire.An x-ray was obtained to ensure complete catheter removal, and no catheter fragments were noted.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill boulevard; morrisville NC 27560
• MDR Report Key: 8398454
• MDR Text Key: 138075482
• Report Number: 8398454
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN045585
• Device Catalogue Number: AB-19608-K
• Device Lot Number: 23F18G0412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 22995 DA
• Patient Weight: 55