MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ACCESS TRAY; PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number ASK-01663-MST

Device Problem Wrinkled (2614)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2015

Event Type  malfunction  

Event Description

It was reported the sheath was being placed into the patient's basilic vein.During insertion, the sheath outer (gray) part "crinkled up" during insertion.As a result, another kit was opened and placed successfully.There was a delay in treatment with no patient harm and no patient death or complications reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through examination of a returned product sample.The customer provided a sheath with a dilator inserted through it.There were no signs of damage to the dilator tip.The sheath tip had two folds on the body located at 1.6 and 2.2 cm from the tip.Microscopic examination of the sheath tip revealed that it was flapped back at one location.The remainder of the tip had been slightly pushed back.The two folds had small wrinkles on either side with faint white marks indicating stress.A review of manufacturing records did not yield any relevant findings.Based on the condition of the sheath and the information provided, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: ACCESS TRAY
• Type of Device: PERIPHERALLY INSERTED 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: 4925178
• MDR Text Key: 6032701
• Report Number: 1036844-2015-00315
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: ASK-01663-MST
• Device Lot Number: 23F15C0653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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