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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 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.
 
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Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill boulevard
morrisville NC 27560
MDR Report Key8398454
MDR Text Key138075482
Report Number8398454
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 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
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN045585
Device Catalogue NumberAB-19608-K
Device Lot Number23F18G0412
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/27/2019
Event Location Hospital
Date Report to Manufacturer03/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/07/2019 Patient Sequence Number: 1
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