MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, CONDUCTION, ANESTHETIC

Model Number IPN045729

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

Large leak noted in epidural catheter proximal to snap-lock adapter, after test dose administered.Catheter removed w/o injury to pt.Another kit opened and successfully administered epidural w/o difficulty.

• Brand Name: ARROW
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12473746
• MDR Text Key: 271469682
• Report Number: 12473746
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902114430
• UDI-Public: (01)10801902114430(17)220430(10)23F21EOO17
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN045729
• Device Catalogue Number: ASK-17019-SM
• Device Lot Number: 23F21EOO17
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Weight: 71