MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER LEG BAG MED 48CS (12BX/CS)

Catalog Number 49165

Device Problems Restricted Flow rate (1248); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 ot returned.

Event Description

It was reported that when the patient connects the leg bag directly to his male external catheter, discarding the extension tubing, the urine will not drain into the bag.It was reported that the urine therefore backs up into the male external catheter, causing it to come off.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.This product is obsolete, therefore, bard is unable to determine the associated labeling to review.The equivalent product ifus were found to be adequate based on past reviews.

Event Description

It was reported that when the patient connected the leg bag directly to his male external catheter, discarded the extension tubing, the urine did not drain into the bag.It was also reported that the urine allegedly backed up into the male external catheter, causing it to come off.

• Brand Name: ROCHESTER LEG BAG MED 48CS (12BX/CS)
• Type of Device: LEG BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7570523
• MDR Text Key: 110286169
• Report Number: 1018233-2018-02078
• Device Sequence Number: 1
• Product Code: FAQ
• UDI-Device Identifier: 00801741071508
• UDI-Public: (01)00801741071508
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 49165
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1