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

Catalog Number 750307

Device Problem Break (1069)

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.The device was not returned.

Event Description

It was reported that when pulling back the syringe to pull up fluid, after about 20 or 30 mls, the vacuum seal broke and all of the fluid fell out of the device.No medical intervention required.

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.H3 other text : the device was not returned.

Event Description

It was reported that when pulling back the syringe to pull up fluid, after about 20 or 30 mls, the vacuum seal broke and all of the fluid fell out of the device.No medical intervention required.

• Brand Name: BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE
• Type of Device: PISTON SYRINGE TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9889920
• MDR Text Key: 186750515
• Report Number: 1018233-2020-02189
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741051111
• UDI-Public: (01)00801741051111
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 750307
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1