MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER MIDLINE CATHETER, 4F SL

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the facility had two issues of bard midlines where the stiffening wire got hung up in the midline.Nurse manager asked the rn's placing them to remove the stiffening wire before placing it in the patient and load midline with floppy wire for the interim.It was stated both cases were ones that they had to completely pull everything out and start over.This report addresses the second event.

• Brand Name: POWER MIDLINE CATHETER, 4F SL
• Type of Device: MIDLINE CATHETER
• 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: 9252310
• MDR Text Key: 164290580
• Report Number: 3006260740-2019-03371
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741184147
• UDI-Public: (01)00801741184147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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: CK000908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2019
• 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