MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 32OZ., STERILE

Catalog Number	150103
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Type of Reportable Event	Serious Injury
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 patient experienced a rash on his leg from the leg bag, for which he went to the emergency room where he was prescribed a cream that was not over the counter.
Event or Problem Description
It was reported that the patient experienced a rash on his leg from the leg bag, for which he went to the emergency room where he was prescribed a cream that was not over the counter.
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: separate notches within circles.Put 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.To empty dispoz-a-bag leg bag, remove cap at bottom.Important: hold green connector firmly while removing cap.Bard dispoz-a-bag accessories: leg bag holder.Extension tubing.1-3/4"/1.905cm wide leg bag strap.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Rx only: caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use: do not resterilize.Do not use if package is damaged.Catalog number.Contains or presence of natural rubber latex.Lot number.Units.Sterilized by ethylene oxide.Caution: consult accompanying documents.Use by.Warning: 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.The device was not returned.

• Brand Name: LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS), 32OZ., STERILE
• Common Device Name: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7434689
• Report Number: 1018233-2018-01227
• Device Sequence Number: 1677877
• Product Code: KNX
• UDI-Device Identifier: 00801741050732
• UDI-Public: (01)00801741050732
• 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): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 150103
• Device Lot Number: NGBS0923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention