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.
Event or Problem Description
It was reported that piston syringes were not maintaining their suction during usage, and the liquid was pouring back out.The complainant noted "you have to put your thumb in the ring and keep the tip of the syringe upward after the solution has been drawn in order that the liquid could stay in the syringe.That¿s too much maintenance." the complainant further went on to say that the devices were used correctly.
Additional Manufacturer Narrative
Upon further review, bd has determined that this event is not reportable and has therefore been downgraded.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.
Event or Problem Description
It was reported that piston syringes were not maintaining their suction during usage, and the liquid was pouring back out.The complainant noted "you have to put your thumb in the ring and keep the tip of the syringe upward after the solution has been drawn in order that the liquid could stay in the syringe.That¿s too much maintenance." the complainant further went on to say that the devices were used correctly.

• 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: 9787963
• Report Number: 1018233-2020-01539
• Device Sequence Number: 16960847
• 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: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 0038470
• Device Lot Number: NGDX4492
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1