MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO¿ VALVE

Catalog Number	150919
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 customer found the ifu for the leg bag to be confusing because the photo of the bag on the ifu had leg straps even though the leg bag in question did not come with straps.
Event or Problem Description
It was reported that the customer found the ifu for the leg bag to be confusing because the photo of the bag on the ifu had leg straps even though the leg bag in question did not come with straps.
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: "sterile unless package is opened or damaged.A vinyl leg bag to be used with male external catheters, foley catheters or most other types of urinary catheters.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.Bard, dispoz-a-bag, and flip-flo are trademarks and/or registered trademarks of c.R.Bard, inc.".

• Brand Name: LEG BAG WITH FLIP-FLO¿ VALVE
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7707885
• Report Number: 1018233-2018-02910
• Device Sequence Number: 11131541
• Product Code: KNX
• UDI-Device Identifier: 00801741050893
• UDI-Public: (01)00801741050893
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 06/30/2020
• Device Catalogue Number: 150919
• Device Lot Number: NGBT1123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1