MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER 3F, SINGLE-LUMEN

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr0288 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the health professional cut himself on one of the purple scalpels from his custom kit ck000860.This caused a minor cut.He mentioned that the scalpel was extremely difficult to safety and unsafety causing his finger to drag over the blade.

• Brand Name: BARD POWERMIDLINE CATHETER 3F, SINGLE-LUMEN
• 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: 12577185
• MDR Text Key: 274759077
• Report Number: 3006260740-2021-04130
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741162763
• UDI-Public: (01)00801741162763
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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: CK000860
• Device Lot Number: REFR0288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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