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

Catalog Number 750310

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

Patient Problems No Patient Involvement (2645); 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 there was no piston syringe included in the tray.

Event Description

It was reported that there was no piston syringe included in the tray.

Manufacturer Narrative

The reported event was confirmed.The product could not be used for treatment since only the packaging was included.The device did not meet specifications, which was influenced by the reported failure.Visual evaluation of the sample noted one opened piston irrigation syringe tray.Upon looking into the tray, it was noted that the tray was empty aside from the tray packaging.Missing components were not permitted.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be machine speed out of parameters.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿contents: 1 graduated solution container 1 graduated plastic collection basin.1 50 cc (1-2/3 oz) bulb syringe".

• Brand Name: BARD PISTON ECONOMY IRRIGATION TRAY WITH 70ML PISTON SYRINGE,LATEX-FREE,STERILE
• Type of Device: PISTON IRRIGATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9081885
• MDR Text Key: 188878705
• Report Number: 1018233-2019-05735
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741051128
• UDI-Public: (01)00801741051128
• 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: 10/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 750310
• Device Lot Number: NGDQ2786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1