MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG; DRAIN BAG

Model Number 153509

Device Problems Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

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 a kink in the tubing when the bag was received.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿urine will not flow through tubing¿ with a potential root cause of "kinked tubing".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: ¿100% latex-free closed system urinary drainage bag.- 4 liter capacity.- 4000 ml approximate volume capacity drainage bag.- bard ez-lok® sampling port.- attached sheeting clip.- control-fit¿ outlet device" correction: d10, h3.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 there was a kink in the tubing when the bag was received.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Type of Device: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9171739
• MDR Text Key: 167400843
• Report Number: 1018233-2019-06357
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741029608
• UDI-Public: (01)00801741029608
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 153509
• Device Catalogue Number: 153509
• Device Lot Number: NGDS0108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1