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

Catalog Number	0935830
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the bulb syringe seemed deformed.
Additional 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 or Problem Description
It was reported that the bulb syringe seemed deformed.

• Brand Name: 3 OZ EAR SYR BULK 150
• Common Device Name: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8898779
• Report Number: 1018233-2019-04767
• Device Sequence Number: 2716262
• Product Code: KYZ
• UDI-Device Identifier: 10801741075992
• UDI-Public: (01)10801741075992
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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 Catalogue Number: 0935830
• Device Lot Number: BMCXAM06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1