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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 36MM 30BX; MALE EXTERNAL CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 36MM 30BX; MALE EXTERNAL CATHETER Back to Search Results
Model Number 37304
Device Problems Backflow (1064); Nonstandard Device (1420); Inadequacy of Device Shape and/or Size (1583)
Patient Problem Urinary Tract Infection (2120)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the male external catheter was too narrow where it connects to the patient tubing; and allows urine to flow back into the catheter.The patients alleged that uti (urinary tract infections) have occurred during the use of the male external catheter.It is unknown at this time if treatment was received for the urinary tract infections.
 
Manufacturer Narrative
The reported event was unconfirmed.The visual evaluation noted 33 unopened spirit mecs were received.No obvious defects.The samples were tested according to the general inspection level ii/single sampling plan.Eight samples were opened and the funnel inner diameters were measured.The id's measured to be 0.3215", 0.3260", 0.3320", 0.3240", 0.3285", 0.3240", 0.3345", 0.3365", which were found to be within specification (0.33" +/- 0.01").The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication do not use on irritated or compromised skin.Precaution do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Open package at perforation.To remove plastic insert, squeeze catheter at the top of the white cone and pull to release.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.".
 
Event Description
It was reported that the male external catheter was too narrow where it connects to the patient tubing; and allows urine to flow back into the catheter.The patients alleged that uti (urinary tract infections) have occurred during the use of the male external catheter.It is unknown at this time if treatment was received for the urinary tract infections.
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 36MM 30BX
Type of Device
MALE EXTERNAL CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8429674
MDR Text Key139163363
Report Number1018233-2019-01388
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741071201
UDI-Public(01)00801741071201
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/28/2023
Device Model Number37304
Device Catalogue Number37304
Device Lot NumberJUCW0188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Date Manufacturer Received05/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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