MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 3 OZ EAR SYR BULK 150; SYRINGE

Catalog Number 0935830

Device Problem Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 the bulb syringe seemed deformed.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Evaluation showed that the primary sample was highly deformed on multiple sides, and the other sample, which was sent for comparison, was also slightly deformed on one small portion.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The reported event is unrelated to labeling.Therefore, a labeling review was not required.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the bulb syringe seemed deformed.

• Brand Name: 3 OZ EAR SYR BULK 150
• Type of Device: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8898779
• MDR Text Key: 161776032
• Report Number: 1018233-2019-04767
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741075992
• UDI-Public: (01)10801741075992
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0935830
• Device Lot Number: BMCXAM06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1