MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 2-L PICC KIT: 5 FR X 40 CM; CATHETER, PERCUTANEOUS

Catalog Number UK-04052-RDE1

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device product (catalog #uk-04052-rde1) is not intended for sale in the us.Similar device/component sold in the us.

Event Description

Catheter hub involved in incident disconnected from extension line/ tubing.Issue noted during use on patient and was not replaced as patient was end of life care.No patient complications or death.

Manufacturer Narrative

(b)(4).The customer returned one 2-lumen picc for evaluation.Visual examination revealed the distal luer was separated from the extension line.Microscopic examination revealed remnants of extension line extrusion remained within the luer.This defect is consistent with a molding issue.The total length of the catheter body measured to be 16.0" which is within specifications of 15.875-16.063" per product drawing.The outer diameter of the distal extension line measured 0.09565", which is within specifications of 0.093-0.097" per distal extension line extrusion graphic.The inner diameter of the distal extension line measured 0.058", which is within specifications of 0.055-0.059" per distal extension line extrusion graphic.The proximal lumen was flushed with no blockages or leaks detected.A manual tug test confirmed the proximal lumen was fully secured within the luer hub.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested.Do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of a separated luer hub was confirmed by complaint investigation of the returned sample.The distal luer hub was separated from the lumen and contained damage consistent with a molding issue.A device history record review was performed with no relevant findings.Based on the sample received, manufacturing (molding) caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.

Event Description

Catheter hub involved in incident disconnected from extension line/ tubing.Issue noted during use on patient and was not replaced as patient was end of life care.No patient complications or death.

• Brand Name: ARROW 2-L PICC KIT: 5 FR X 40 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10302656
• MDR Text Key: 199726050
• Report Number: 3006425876-2020-00633
• Device Sequence Number: 1
• Product Code: DQY
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2021
• Device Catalogue Number: UK-04052-RDE1
• Device Lot Number: 71F19D0455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1