MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL; WIRE, GUIDE, CATHETER

Catalog Number FA-04018

Device Problems Split (2537); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device indicates the catheter is split/torn.

Event Description

The customer reports the catheter split during insertion.

Manufacturer Narrative

(b)(4).The customer returned one single lumen arterial catheter for evaluation.The catheter body showed evidence of use in the form of dried blood.Visual and microscopic examination of the catheter distal tip revealed that the material on one side of the tip was deformed/damaged.The tip of the catheter was split, folded back, had ripples, and the cracks in the tip contained white discoloration, indicating stress.No other damage to the catheter was observed.The length of the entire catheter (including the hub) measured 5.25", which is within specification.The outer and inner diameter of the catheter body were also found to be within specification.The catheter tip could not accurately be measured due to the condition of the returned sample.A device history record review was performed on the catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit describes suggested techniques for catheter insertion.It states to "firmly hold introducer needle hub in position and advance catheter forward, with a slight rotating motion, over spring-wire guide into vessel." the ifu also cautions the user to "not reinsert needle in to catheter to minimize risk of catheter damage." the reported complaint that the arterial catheter was split was confirmed during visual examination of the returned sample.The returned catheter tip was split, folded back, and contained white stress marks.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports the catheter split during insertion.

• Brand Name: ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7472266
• MDR Text Key: 106875066
• Report Number: 1036844-2018-00124
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: FA-04018
• Device Lot Number: 23F17E0373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1