MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER BASIC KIT 4F SL 20CM

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp1993 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that during placement, the guide gets stuck in the patient's vein and breaks down.The patient had to be transplanted.No other information was provided.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT 4F SL 20CM
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12395046
• MDR Text Key: 269327471
• Report Number: 3006260740-2021-03624
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: P6154118
• Device Lot Number: REFP1993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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): Other