MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 19OZ.; DISPO O BAG

Catalog Number	150102
Medical Device Problem Code	Partial Blockage (1065)
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.
Event or Problem Description
It was reported that there was a clear thin film of plastic material over the end of the drain valve blocking any fluid from being drain.A new bag was placed and it drain properly.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed since the reported failure could not be reproduced.The device did not fail to meet specifications.The product was used for treatment purposes.The product was not related to the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), 19 oz dispoz-a-bag leg drain bag.Visual inspection of the sample noted no visible defects.The bag was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).The solution flowed without issue through the inlet port, into the bag, and out of the outlet port.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿to empty dispoz-a-bag leg bag, remove cap at bottom.Important: hold green connector firmly while removing cap." 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.
Event or Problem Description
It was reported that there was a clear thin film of plastic material over the end of the drain valve blocking any fluid from being drain.A new bag was placed and it drain properly.No medical intervention was reported.

• Brand Name: LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 19OZ.
• Common Device Name: DISPO O BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9075942
• Report Number: 1018233-2019-05698
• Device Sequence Number: 160676
• Product Code: KNX
• UDI-Device Identifier: 00801741050725
• UDI-Public: (01)00801741050725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: Health Professional
• Device Catalogue Number: 150102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1