MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW TELEFLEX ARTERIAL LINE KIT; WIRE, GUIDE, CATHETER

Lot Number 13F20C065Q

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/06/2020

Event Type  Injury  

Event Description

Arterial line foreign body removal s/p disconnect during suturing catheter.Vss imaging obtained, observed by md's throughout, vascular surgery attempted to remove catheter however, unable to remove at this time.Fda safety report id# (b)(4).

• Brand Name: ARROW TELEFLEX ARTERIAL LINE KIT
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
• MDR Report Key: 10612851
• MDR Text Key: 209564003
• Report Number: MW5096979
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Lot Number: 13F20C065Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR