MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EAR / ULCER SYRINGE (BLUE) 2 OZ. BULK / 250

Catalog Number	9035820
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 in the vaginal delivery kits were flat.The health professional stated, while trying to suction a baby at delivery, the bulb syringe would not function.No medical intervention was required.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause of the reported event could be damage during shipping due to which the bulb syringe was flat, resulting in failure to suction.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 is 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the bulb syringe in the vaginal delivery kits were flat.The health professional stated, while trying to suction a baby at delivery, the bulb syringe would not function.No medical intervention was required.

• Brand Name: EAR / ULCER SYRINGE (BLUE) 2 OZ. BULK / 250
• Common Device Name: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9315390
• Report Number: 1018233-2019-07269
• Device Sequence Number: 11479600
• Product Code: KYZ
• UDI-Device Identifier: 10801741075985
• UDI-Public: (01)10801741075985
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 9035820
• Device Lot Number: BMDQAM01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1