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

Catalog Number 750379

Device Problem Suction Problem (2170)

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 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 Description

It was reported that the syringe did not suction.

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 Description

It was reported that the syringe did not suction.

• Brand Name: BARD® PISTON ENTERAL IRRIGATION SYRINGE
• Type of Device: POLE BAG WITH PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6941959
• MDR Text Key: 89936501
• Report Number: 1018233-2017-05233
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741052637
• UDI-Public: (01)00801741052637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2022
• Device Catalogue Number: 750379
• Device Lot Number: BMBRAM01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1