MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number 13F20K0154

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

When trimming picc for placement, i retracted the vps wire.It began to gather in center of the picc during retraction in an accordion like fashion.Upon inspection, it was noted to have two flattened crimps in picc.New picc obtained for procedure, no injury to patient, but possibly a manufacturing issue.Fda safety report id # (b)(4).

• Brand Name: PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC
• MDR Report Key: 11261178
• MDR Text Key: 230128499
• Report Number: MW5099118
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: (01)50801902120781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Lot Number: 13F20K0154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR