MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 1-L 16 GA X 27-1/2" (70 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number PS-01671

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint description: when performing the puncture, it failed and the peel away is damaged, so another catheter is requested.

Manufacturer Narrative

(b)(4).The customer returned one opened kit containing a catheter and peel-away sheath for evaluation.The sample contained obvious signs of use in the form of biological material.Visual examination of the peel-away sheath revealed the distal tip was frayed and split, indicating excessive force was used.Visual examination of the catheter did not reveal any defects or anomalies.The outer diameter of the returned catheter and the inner diameter of the distal sheath tip were measured and were found to be within specification.The returned catheter was able to pass through the returned sheath with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user to perform a skin wheal prior to dilating skin or inserting sheath.The customer report of sheath damage was confirmed by complaint investigation.The returned sheath tip was frayed and split, indicating excessive force.The returned catheter was able to pass through the sheath with minimal resistance.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

Complaint description: when performing the puncture, it failed and the peel away is damaged, so another catheter is requested.

• Brand Name: ARROW PICC SET: 1-L 16 GA X 27-1/2" (70 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7719490
• MDR Text Key: 115066216
• Report Number: 9680794-2018-00161
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

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: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: PS-01671
• Device Lot Number: 14F18A0440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR