MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWER MIDLINE CATHETER (5F) (DUAL-LUMEN) (20CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recz1040 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recz1040) have been reported from the same facility.

Event Description

It was reported that when attempting to place a midline, the guidewire broke and part of the broken guidewire remained in the patient.It is stated that the piece of guidewire was pulled out of the patient and an x-ray was done to ensure that no pieces remained in the patient.No other information was provided.It was stated that this occurred three separate times.This report addresses the second device.

• Brand Name: BARD POWER MIDLINE CATHETER (5F) (DUAL-LUMEN) (20CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: 8599819
• MDR Text Key: 144708864
• Report Number: 3006260740-2019-01347
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741147517
• UDI-Public: (01)00801741147517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000805
• Device Lot Number: RECZ1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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
• Patient Outcome(s): Required Intervention