MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 32 OZ., STERILE; DRAIN BAG

Catalog Number	150732
Health Effect - Clinical Code	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.
Event or Problem Description
It was reported that the drain bag developed a vapor lock and did not drain properly.
Additional Manufacturer Narrative
The reported issue could not be confirmed after visual and functional.The received sample was functionally tested by passing water through an in house 16fr.Catheter (catheter bard).Observed no drainage problems; the flow was continuous during the test on the sample received.The drainage test for customer complaint-catheters/drainage bags indicated that 250cc must be drained in 64 seconds maximum.The results were the following: time to drain 250cc: 50 sec.The sample received reached the intended drainage in less than 64 seconds.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: separate notches within circles.Pull straps through holes and around leg.Position bag on leg with flutter valve at top.Attach catheter or extension tubing to top inlet.When wearing bag below knee, attach bard extension tubing (catalog no.150615 or 4a4194).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." (b)(4).
Event or Problem Description
It was reported that the drain bag developed a vapor lock and did not drain properly.

• Brand Name: LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 32 OZ., STERILE
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6669018
• Report Number: 1018233-2017-03287
• Device Sequence Number: 43870
• Product Code: KNX
• UDI-Device Identifier: 00801741050862
• UDI-Public: (01)00801741050862(17)210731(10)NGAU4458
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 07/31/2021
• Device Catalogue Number: 150732
• Device Lot Number: NGAU4458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1