MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, PERCUTANEOUS

Model Number IPN029818

Device Problems Fitting Problem (2183); Physical Resistance/Sticking (4012)

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

Event Date 01/06/2020

Event Type  malfunction  

Event Description

Doctor was unable to thread catheter over guide wire included in the kit.Guide wire would not fit through catheter.Doctor also reported some resistance threading the catheter over the guide wire in the kit, during (2) different incidences in the last week.Manufacturer notified of problems.Teleflex.Ask-00520-fam - arterial cath set: 20ga x 5cm.Lot number 13f19a0626.

• Brand Name: ARROW
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9610472
• MDR Text Key: 175675312
• Report Number: 9610472
• Device Sequence Number: 1
• Product Code: DQY
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN029818
• Device Catalogue Number: ASK-00520-FAM
• Device Lot Number: 13F19A0626
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA