MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN) (MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Edema (1820); Infiltration into Tissue (1931)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recr1199 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that fluid leaks were found at the access site when infusion on september 19, two months after the catheter placement.Serious extravasation occurred when normal saline was being injected with a syringe.Local edema was found in the patient.The catheter was removed and found a sand hole at the 805 cm scale of the catheter.

• Brand Name: POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN) (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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 9173523
• MDR Text Key: 162691529
• Report Number: 3006260740-2019-02972
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139123
• UDI-Public: (01)00801741139123
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8194118
• Device Lot Number: RECR1199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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