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

Model Number IPN035833

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

Staff members were using the arrow percutaneous sheath introducer kit.One of the providers had used one of the scalpels included in the kit.After use, the scalpel was put back into the sheath.The scalpel went all the way through the protective plastic sheath and punctured the provider.It is noted that the plastic is very thin, and it easily punctured.

• Brand Name: ARROW
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9510311
• MDR Text Key: 172413656
• Report Number: 9510311
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2019

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: IPN035833
• Device Catalogue Number: MZ-09883-S
• Device Lot Number: 13F19G0460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29565 DA