MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PISTON TYPE IRRIGATION SYRINGE 70ML WITH LUER TIP ADAPTER, PLASTIC, STERILE; PISTON SYRINGE

Catalog Number	0038470
Health Effect - Clinical Code	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.The device was not returned.
Event or Problem Description
It was reported that the syringe did not maintain suction.
Event or Problem Description
It was reported that the syringe did not maintain suction.
Additional Manufacturer Narrative
Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.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.The device was not returned.

• Brand Name: PISTON TYPE IRRIGATION SYRINGE 70ML WITH LUER TIP ADAPTER, PLASTIC, STERILE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9922661
• Report Number: 1018233-2020-02339
• Device Sequence Number: 14291377
• Product Code: KYZ
• UDI-Device Identifier: 00801741049323
• UDI-Public: (01)00801741049323
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 0038470
• Device Lot Number: NGDY1673
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1