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

Catalog Number 9035820

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problems No Consequences Or Impact To Patient (2199); 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 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.

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 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
• Type of Device: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9315390
• MDR Text Key: 177802996
• Report Number: 1018233-2019-07269
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741075985
• UDI-Public: (01)10801741075985
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9035820
• Device Lot Number: BMDQAM01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1