MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PISTON ENTERAL IRRIGATION SYRINGE; POLE BAG WITH PISTON SYRINGE

Catalog Number	750379
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.The information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the syringe did not suction.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿not made with natural rubber latex not for i.V.Use.Non-sterile.Single patient use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge.Suggested procedure: open flap and remove syringe.Write patient name, date, and time of service.Hang bag on i.V.Pole.Fill syringe with water and attach to feeding port to flush tube.Rinse syringe thoroughly with hot water after each use.Place syringe in bag and reseal flap for later use.Must be changed every 24 hours." (b)(4).
Event or Problem Description
It was reported that the syringe did not suction.

• Brand Name: BARD® PISTON ENTERAL IRRIGATION SYRINGE
• Common Device Name: POLE BAG WITH PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6941959
• Report Number: 1018233-2017-05233
• Device Sequence Number: 13652106
• Product Code: KYZ
• UDI-Device Identifier: 00801741052637
• UDI-Public: (01)00801741052637
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: Lay User/Patient
• Device Expiration Date: 04/05/2022
• Device Catalogue Number: 750379
• Device Lot Number: BMBRAM01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1