MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number SI-21142

Device Problems Crack (1135); Gas/Air Leak (2946)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that during puncturing, aire was aspirated.When the plastic part of needle was investigated it was noted that the needle hub had several cracks.A new cvc was used.

Manufacturer Narrative

Qn# (b)(4).The customer returned an introducer needle attached to a syringe for evaluation.The needle and needle hub were visually examined under magnification.No cracks or any other defects were observed on the needle or needle hub.The needle hub was tested for leaks by attaching a lab syringe filled with water to the needle hub and then depressing the plunger to expel the water.Water exited the needle bevel and no leaks were observed from the needle hub.Needle also aspirated water as expected.A device history record review was performed and no relevant findings were identified.The customer report of a damaged needle hub could not be confirmed through visual or functional testing of the returned sample.No damage was observed on the needle/hub during visual inspection and no leaks were observed during leak test.No problem was found on the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that during puncturing, aire was aspirated.When the plastic part of needle was investigated it was noted that the needle hub had several cracks.A new cvc was used.

• Brand Name: ARROW MULTI-LUMEN/PSI SET
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8658449
• MDR Text Key: 146654346
• Report Number: 3006425876-2019-00386
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: SI-21142
• Device Lot Number: 71F19C2423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1