MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CDC-45703-XP1A

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the needle from the kit is bent and broke.The reported issue was detected during use.No patient injury or complication reported.

Manufacturer Narrative

(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing a broken introducer needle and the product lidstock.The needle cannula was broken adjacent to the hub and the separated piece was bent.A probable cause of the introducer needle breaking cannot be determined from the photos and without the sample to evaluate.A device history record review was performed on the needle and no relevant findings were identified.The report that the needle cannula broke was confirmed through examination of the customer supplied photo.The image showed the needle cannula was broken adjacent to the hub; however, the actual complaint sample was not returned for evaluation.The device history records for the introducer needle were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the needle damage could not be determined based upon the information provided and without the actual complaint sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the needle from the kit is bent and broke.The reported issue was detected during use.No patient injury or complication reported.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7494224
• MDR Text Key: 107588660
• Report Number: 1036844-2018-00131
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

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: No Information
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F17L0614
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1