MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM; PEDIATRIC MULTI LUMEN CATHETER PRODU

Catalog Number CS-14402

Device Problem Unraveled Material (1664)

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

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is for the first in a series of three consecutive product issues with the same patient.The subsequent two events have been reported under mdr#s 1036844-2015-00592 and 1036844-2015-00593.

Event Description

It was reported the catheter was being placed into the left subclavian vein of a few month old child in the pediatric icu.During insertion, the guide wire unraveled.As a result, a new kit was used.

Manufacturer Narrative

(b)(4).Device evaluation: the reported event was confirmed through examination of a returned product sample.The customer returned a guidewire inserted through a catheter that was severely bent at the distal tip.The guidewire was unraveled and microscopic examination revealed that the core wire was separated 1.5 cm from the weld at the j-tip.No pieces of wire appeared to be missing.A lab inventory wire was able to pass through the catheter with slight resistance at the bend.The device history records for the guide wire and catheter were reviewed with no relevant findings.The provided instructions caution that withdrawing the guidewire against the needle bevel or use of excessive force during removal could damage or break the wire.Since it appears that the catheter was kinked during insertion resulting in damage to the guidewire, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: PEDIATRIC MULTI LUMEN CATHETER PRODU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5309791
• MDR Text Key: 33842496
• Report Number: 1036844-2015-00591
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: CS-14402
• Device Lot Number: 23F15A1312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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
• Patient Weight: 3