MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recn0579 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that guide wire was kinked at an angle of 90 at 10 cm from fitting and was ruptured in the process of catheterization on (b)(6) 2020.The guide wire could not be withdrawn after the completion of catheterization.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI
• 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: 10032214
• MDR Text Key: 190142855
• Report Number: 3006260740-2020-01691
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296
• Combination Product (y/n): N
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: RECN0579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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