MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.) ARROW EPIDURAL CATHETERIZATON KIT; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05503

Device Problems Break (1069); Stretched (1601)

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

Event Date 08/29/2016

Event Type  malfunction  

Event Description

Arrow epidural catheter retained in epidural space after insertion.Epidural needle removed and catheter appeared stretched and broke apart with adjustment at 13 cm mark per physician provider.

• Brand Name: ARROW EPIDURAL CATHETERIZATON KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.(SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 5966196
• MDR Text Key: 55231532
• Report Number: 5966196
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2016,08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F16C0975
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 68