MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC ARROW; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number AK-25142-CDC

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

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

Event Date 01/23/2023

Event Type  No Answer Provided  

Event Description

During uncomplicated quinton catheter placement, ij accessed with needle without difficulty.Then noticed difficulty threading wire, so attempted to retract wire to retry.At this point wire would not retract from the needle, ultimately leading to needing to pull out needle/wire together, with resistance noted getting wire out of skin.Once both needle and wire out of skin, still unable to separate needle from wire - appeared that wire became caught on the bevel of the needle and became stuck.

• Brand Name: ARROW
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC; 35 innovation way; wyomissing PA 19610
• MDR Report Key: 16545594
• MDR Text Key: 311327390
• Report Number: 16545594
• Device Sequence Number: 1
• Product Code: MPB
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: AK-25142-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1