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 05/15/2023

Event Type  malfunction  

Event Description

It was reported that the male external catheter had a urine backflow and leaked at the top.Customer also stated that on some occasions urine did not drain into the leg bag and stayed in the 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.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "obstruction in tube, kinked tubing ,wrong tubing dimensions".It was unknown whether the device had met relevant specifications.The device history record review could not be performed without a lot number.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 male external catheter had a urine backflow and leaked at the top.Customer also stated that on some occasions urine did not drain into the leg bag and stayed in the 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: 17070054
• MDR Text Key: 316707318
• Report Number: 1018233-2023-04052
• Device Sequence Number: 1
• Product Code: FAQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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: 06/15/2023
• 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
• Patient Sex: Male