MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN HOME CARE URINE COLLECTION

Device Problem Restricted Flow rate (1248)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient used a male external catheter and a leg bag for severe incontinence, they had following prostate surgery which has helped them a lot.Stated that the bag was in the lower leg much lower than the male external catheter, and it did get filled up with urine as expected.The issue was that the extension tube that connects the catheter to the leg bag remains full all the time even if there was a lot of room in the bag.Patient did not understand why, when urine was already draining and going into the bag with gravity, the extension tube remains full all the time from the tip of the catheter to its connection to the leg bag.So, essentially, the tip of the catheter was full of urine, the entire 18-inch of extension tube was full of urine even if there was lot of room in the bags as they usually drain it out when the bag had only 100-300ml of urine for a capacity of 500ml.If more urine comes in the bag, the bag was able to expand but the urine in the extension tube did not fully drain into the bag.Then, when they drain the urine out of the bag, the bag empties out completely but the extension tube remains full.Stated that this makes them worried about getting urinary tract infection since the tip of the penis was constantly wet from the urine that was always staying in the tip of the catheter including the extension tube.Perhaps they were doing something wrong while wearing the catheter or the bag.Patient needs someone could explain the reason for this issue and how to fix it, so the extension tube remains empty of urine if there was enough room in the bag which was lower than the level of the extension tube.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to "tubing does not meet specification".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.The information provided by bd represents all 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 Description

It was reported that the patient used a male external catheter and a leg bag for severe incontinence, they had following prostate surgery which has helped them a lot.Stated that the bag was in the lower leg much lower than the male external catheter, and it did get filled up with urine as expected.The issue was that the extension tube that connects the catheter to the leg bag remains full all the time even if there was a lot of room in the bag.Patient did not understand why, when urine was already draining and going into the bag with gravity, the extension tube remains full all the time from the tip of the catheter to its connection to the leg bag.So, essentially, the tip of the catheter was full of urine, the entire 18-inch of extension tube was full of urine even if there was lot of room in the bags as they usually drain it out when the bag had only 100-300ml of urine for a capacity of 500ml.If more urine comes in the bag, the bag was able to expand but the urine in the extension tube did not fully drain into the bag.Then, when they drain the urine out of the bag, the bag empties out completely but the extension tube remains full.Stated that this makes them worried about getting urinary tract infection since the tip of the penis was constantly wet from the urine that was always staying in the tip of the catheter including the extension tube.Perhaps they were doing something wrong while wearing the catheter or the bag.Patient needs someone could explain the reason for this issue and how to fix it, so the extension tube remains empty of urine if there was enough room in the bag which was lower than the level of the extension tube.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient used a male external catheter and a leg bag for severe incontinence, they had following prostate surgery which has helped them a lot.Stated that the bag was in the lower leg much lower than the male external catheter, and it did get filled up with urine as expected.The issue was that the extension tube that connects the catheter to the leg bag remains full all the time even if there was a lot of room in the bag.Patient did not understand why, when urine was already draining and going into the bag with gravity, the extension tube remains full all the time from the tip of the catheter to its connection to the leg bag.So, essentially, the tip of the catheter was full of urine, the entire 18-inch of extension tube was full of urine even if there was lot of room in the bags as they usually drain it out when the bag had only 100-300ml of urine for a capacity of 500ml.If more urine comes in the bag, the bag was able to expand but the urine in the extension tube did not fully drain into the bag.Then, when they drain the urine out of the bag, the bag empties out completely but the extension tube remains full.Stated that this makes them worried about getting urinary tract infection since the tip of the penis was constantly wet from the urine that was always staying in the tip of the catheter including the extension tube.Perhaps they were doing something wrong while wearing the catheter or the bag.Patient needs someone could explain the reason for this issue and how to fix it, so the extension tube remains empty of urine if there was enough room in the bag which was lower than the level of the extension tube.

• Brand Name: UNKNOWN HOME CARE URINE COLLECTION
• Type of Device: UNKNOWN HOME CARE URINE COLLECTION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16961138
• MDR Text Key: 315552924
• Report Number: 1018233-2023-03600
• Device Sequence Number: 1
• Product Code: FAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other