MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 32 OZ., STERILE

Catalog Number	150632
Health Effect - Clinical Code	No Patient Involvement (2645)
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.
Event or Problem Description
It was reported that the complainant tested the bag using water, and the water would not flow into the bag.
Event or Problem Description
It was reported that the complainant tested the bag using water, and the water would not flow into the bag.
Additional Manufacturer Narrative
Received 4 dispoz-a-bag in open packaging.The reported event was unconfirmed, since the problem could not be reproduced.Visual inspection noted no obvious defects.During the evaluation of the samples, the peripheral seal of the bag, the components¿ circular seal for inlet tube and outlet tube were inspected and the back and front part of the vinyl was inspected and no discrepancies were observed.Per functional testing, the 4 samples were filled with water at full capacity and the water entered correctly in the bags without any issues.Afterwards, the water was drained out of the bags and it flowed correctly.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: "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).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." (b)(4).

• Brand Name: LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 32 OZ., STERILE
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7058338
• Report Number: 1018233-2017-06104
• Device Sequence Number: 11133660
• Product Code: KNX
• UDI-Device Identifier: 00801741050848
• UDI-Public: (01)00801741050848
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/02/2018

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: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 150632
• Device Lot Number: NGBQ4308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/26/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1