MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO¿ VALVE, (1 PAIR FABRIC LEG STRAPS, 18" LATEX EXTENSION TUB

Catalog Number 150819

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); 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 pvc extension tubing on the leg bag was twisted and became completely separated from the coloplast male external catheter.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.The device was not returned.

Event Description

It was reported that the pvc extension tubing on the leg bag was twisted and became completely separated from the coloplast male external catheter.

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: "bard® dispose-a-bag® leg bag with flip-flo¿ drainage valve a vinyl leg bag to be used with male external catheters, foley catheters or most other types of urinary catheters.Sterile unless package is opened or damaged.Directions for use: 1.Separate notches within circles.Pull straps through holes and around leg.2.Position bag on leg with flutter valve at top.3.Attach catheter or extension tubing to top inlet.When wearing bag below knee, attach bard® extension tubing (catalog no.150615 or 4a4194).When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector.4.To empty dispoz-a-bag®, push green lever on flip-flo¿ valve out and down.Important: be sure to reclose flip-flo¿ valve after emptying bag.5.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable, local, state and federal laws and regulations.Bard® dispoz-a-bag® accessories: ¿ leg bag holder ¿ 1-3/4¿ wide leg bag strap ¿ deluxe fabric leg bag straps ¿ extension tubing contact c.R.Bard, inc.1-800-526-4455 for information on these and other accessories.(b)(4).Bard, dispoz-a-bag, and flip-flo are trademarks and/or registered trademarks of c.R.Bard, inc.Manufactured in mexico" 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.

Event Description

It was reported that the pvc extension tubing on the leg bag was twisted and became completely separated from the coloplast male external catheter.

• Brand Name: LEG BAG WITH FLIP-FLO¿ VALVE, (1 PAIR FABRIC LEG STRAPS, 18" LATEX EXTENSION TUB
• Type of Device: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7793652
• MDR Text Key: 117706512
• Report Number: 1018233-2018-03626
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 00801741050879
• UDI-Public: (01)00801741050879
• 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,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 150819
• Device Lot Number: NGBV0200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1