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

Lot Number	13F20K0154
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC
• MDR Report Key: 11261178
• Report Number: MW5099118
• Device Sequence Number: 4280081
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: (01)50801902120781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Lot Number: 13F20K0154
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR