MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD LEG BAG, DISPOSABLE, WITH LATEX STRAPS, LARGE 32 OZ., STERILE [SPECIAL]

Catalog Number	150108
Medical Device Problem Code	Restricted Flow rate (1248)
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 urine was backing up in the drain bag tubing.
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: "bard dispoz-a-bag disposable urinary leg bag a vinyl leg bag to be used with male external catheters.Foley catheters or most other types of urinary catheters caution: this product contains natural rubber latex which may cause allergic reactions.* directions for use: 1.Separate notches within circles.Put 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 4a4195).4.To empty dispoz-a-bag leg bag, remove cap at bottom.Important: hold green connector firmly while removing cap.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 - extension tubing* contact c.R.Bard, inc.At 1-800-526-4455 for information of these and other accessories.".
Event or Problem Description
It was reported that the urine was backing up in the drain bag tubing.

• Brand Name: BARD LEG BAG, DISPOSABLE, WITH LATEX STRAPS, LARGE 32 OZ., STERILE [SPECIAL]
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7499900
• Report Number: 1018233-2018-01579
• Device Sequence Number: 13809305
• Product Code: KNX
• UDI-Device Identifier: 00801741050763
• UDI-Public: (01)00801741050763
• 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,distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 10/31/2022
• Device Catalogue Number: 150108
• Device Lot Number: NGBX3104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR