MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATE) ARROW SINGLE LUMEN PICC LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number 14F20G0117

Device Problems Fracture (1260); Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2021

Event Type  Injury  

Event Description

Picc line placed on (b)(6) 2021.Portion of peel-away sheath fractured and retained subcutaneously at access site.Patient returned to have it removed on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: ARROW SINGLE LUMEN PICC LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATE)
• MDR Report Key: 11595365
• MDR Text Key: 243560789
• Report Number: MW5100411
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2021

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
• Device Operator: Health Professional
• Device Lot Number: 14F20G0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 104