MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD PISTON ECONOMY IRRIGATION TRAY WITH 70ML PISTON SYRINGE; PISTON IRRIGATION TRAY

Catalog Number	750310
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 tip of the syringe broke off while inflating the foley balloon.No medical intervention was required.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿inadequate connection to syringe¿ with a potential root cause of "improper dimension or tolerancing".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿single use.Do not reuse.Do not resterilize." 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 tip of the syringe broke off while inflating the foley balloon.No medical intervention was required.

• Brand Name: BARD PISTON ECONOMY IRRIGATION TRAY WITH 70ML PISTON SYRINGE
• Common Device Name: PISTON IRRIGATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9081798
• Report Number: 1018233-2019-05734
• Device Sequence Number: 16183130
• Product Code: KYZ
• UDI-Device Identifier: 00801741051128
• UDI-Public: (01)00801741051128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: Lay User/Patient
• Device Catalogue Number: 750310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1