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

Catalog Number 9035820

Device Problems Device Damaged Prior to Use (2284); Structural Problem (2506); Suction Failure (4039)

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.They tried to suction a baby at delivery and the bulb syringe would not function.

Event Description

It was reported that the bulb syringe in the vaginal delivery kits were flat.They tried to suction a baby at delivery and the bulb syringe would not function.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿inadequate performance during intended use - can¿t inject or withdraw fluid¿ with a potential root cause of ¿part weight/dimensions incorrect - cannot create adequate suction¿.The lot number is unknown therefore the device history record could not be reviewed."sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual." 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.

• Brand Name: EAR / ULCER SYRINGE (BLUE) 2 OZ. BULK / 250
• Type of Device: EAR SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9484032
• MDR Text Key: 180339190
• Report Number: 2020394-2019-05658
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 9035820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1