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

Device Problem Decrease in Suction (1146)

Patient Problem 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 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.

Event Description

It was reported that the 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.

Manufacturer Narrative

Upon further review, bd has determined that this event is not reportable and was 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.

• Brand Name: PISTON TYPE IRRIGATION SYRINGE 70ML WITH LUER TIP ADAPTER, PLASTIC, STERILE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9787822
• MDR Text Key: 185060693
• Report Number: 1018233-2020-01538
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049323
• UDI-Public: (01)00801741049323
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0038470
• Device Lot Number: NGDX4492
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1