MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F BASIC TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Infiltration into Tissue (1931); Pain (1994); Swelling (2091)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt0654 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that patient was receiving chemo and developed pain in their arm.The arm began to swell so the line was removed and chemo infusion stopped.Chemo has leaked as a result.Some extravasation at the time.Patients arm recovered later.Single 4f power picc with securacath r arm line was inserted on (b)(6) 2020 36cm with 5 cm external.It was non aspirating on (b)(6) 2020, cxr ok and urokinase used with success.Non aspirating on (b)(6) 2020 cxr was ok, peripheral bloods taken attended for chemo next day and incident happened.All line care was done in secondary care.No community involvement.

• Brand Name: POWERPICC SOLO CATHETER 4F BASIC TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10491169
• MDR Text Key: 205886358
• Report Number: 3006260740-2020-03131
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139055
• UDI-Public: (01)00801741139055
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 6194118
• Device Lot Number: REDT0654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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