MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 21 GAUGE NEEDLE GUIDE KIT; ULTRASOUND TRANSDUCER AND ACCESSORIES

Model Number	900013B01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redz1883 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during the surgical procedure, a possible quality deviation was evidenced by the nursing team.When opening the package and placing the gel in the probe, it was verified that the cover was punctured, not keeping the procedure sterile.

• Brand Name: 21 GAUGE NEEDLE GUIDE KIT
• Common Device Name: ULTRASOUND TRANSDUCER AND ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11304773
• Report Number: 3006260740-2021-00273
• Device Sequence Number: 3373145
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 900013B01
• Device Catalogue Number: 900013B01
• Device Lot Number: REDZ1883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other