MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE ULTRASOUND NEEDLE GUIDE 18GX48IN.; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 9001C0212

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redz2479 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported presence of a hair was observed during the material opening.No other information was provided.

• Brand Name: SITE-RITE ULTRASOUND NEEDLE GUIDE 18GX48IN.
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11248324
• MDR Text Key: 230218252
• Report Number: 3006260740-2021-00115
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037818
• UDI-Public: (01)00801741037818
• Combination Product (y/n): N
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 9001C0212
• Device Catalogue Number: 9001C0212
• Device Lot Number: REDZ2479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• 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
• Patient Outcome(s): Other