MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MALE EXTERNAL CATHETER

Device Problem Component Missing (2306)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that the customer was provided with four drain bags and a large number of freedom male external catheters, but had no instructions.It was stated that male external catheter was too sticky and the customer had problems getting it off.It took an hour to get it off and it caused a lot of pain.It was also stated that the urine did not appear to be draining into the bag.Representative discussed positioning of bag below the bladder level and how gravity is essential.Also discussed exercising the sides of the bag apart before connecting to male external catheter.Advised against blowing into the bag.The customer noted that they could try changing out the bag to see if that assist.They also noted becton dickinson's suggestion for male external catheter customers is to wrap a warm wet compress around penis to allow adhesive to soften, sit in a warm bath for a few minutes or obtain adhesive remover.No medical intervention was reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "damaged robotic arm".It was unknown whether the device had met specifications.Based on patient code, the product does not appear to have been used.However, the product is intended to be used for treatment purpose but it is unknown whether the product had a relationship with the reported event.The lot number was 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.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the customer was provided with four drain bags and a large number of freedom male external catheters, but had no instructions.It was stated that male external catheter was too sticky and the customer had problems getting it off.It took an hour to get it off and it caused a lot of pain.It was also stated that the urine did not appear to be draining into the bag.Representative discussed positioning of bag below the bladder level and how gravity is essential.Also discussed exercising the sides of the bag apart before connecting to male external catheter.Advised against blowing into the bag.The customer noted that they could try changing out the bag to see if that assist.They also noted becton dickinson's suggestion for male external catheter customers is to wrap a warm wet compress around penis to allow adhesive to soften, sit in a warm bath for a few minutes or obtain adhesive remover.No medical intervention was reported.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15258576
• MDR Text Key: 305381583
• Report Number: 1018233-2022-06568
• Device Sequence Number: 1
• Product Code: NNX
• 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
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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: 09/14/2022
• 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