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
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 there was no piston syringe included in the tray.
Event or Problem Description
It was reported that there was no piston syringe included in the tray.
Additional 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
• Common Device Name: PISTON IRRIGATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9081885
• Report Number: 1018233-2019-05735
• Device Sequence Number: 2183573
• Product Code: KYZ
• UDI-Device Identifier: 00801741051128
• UDI-Public: (01)00801741051128
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1