MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EAR SYRINGE

Model Number 9005290

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

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that there was white powder in components of ear syringe.

Manufacturer Narrative

Per additional information received, it has determined that this mdr event is not reportable.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that there was white powder in components of ear syringe per customer responded back to the follow up on (b)(6) 021, stated that the white powder was on just outside the device and all of the 6,327 has 100 defect from the inspection.

• Brand Name: EAR SYRINGE
• Type of Device: EAR SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11198513
• MDR Text Key: 227742793
• Report Number: 1018233-2020-22607
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741076029
• UDI-Public: (01)10801741076029
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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
• Device Operator: Health Professional
• Device Model Number: 9005290
• Device Catalogue Number: 9005290
• Device Lot Number: BMDUAM04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other