MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); PERIPHERALLY INSERTED CATHETER PRODU

Catalog Number PR-05042

Device Problems Break (1069); Wrinkled (2614)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in the icu, the dilator wrinkled and broke.As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint of during insertion the sheath was damaged was confirmed.Returned was one peel-away sheath/dilator assembly in an opened kit.Visual examination revealed that the sheath assembly was damaged along both score lines.The dilator appeared used but typical; no damage was observed.Microscopic examination revealed that both sides of the sheath body are rippled at 2.0-3.2 cm from the tip.In addition, on one side of the body, proximal of the ripples, the sheath is torn open along the score line and the material is white and stretched.The opposite side of the sheath revealed that the material in the score line is stretched and white but was not opened.The sheath tip edge is pushed back multiple times creating an uneven edge.This damage is consistent with use.Manufacturing was consulted, and has stated that the damage observed and the observation of the white stress material in the deformed areas indicates that stress was applied to the sheath after the extrusion process and likely during use.Instructions for use describe suggested techniques for placement of the sheath and dilator assembly.A device history record review did not reveal any manufacturing related issues.Therefore, operational context caused or contributed to this issue.No further action will be taken.

• Brand Name: PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM)
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5430464
• MDR Text Key: 38017277
• Report Number: 1036844-2016-00116
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K042126
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: PR-05042
• Device Lot Number: 23F15D0986
• Other Device ID Number: 00801902012968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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