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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 1 STANDARD 36MM 30BX
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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 36MM 30BX Back to Search Results
Model Number 35304
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Discomfort (2330)
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.
 
Event Description
It was reported that the catheter was difficult to unroll; the catheter would pull on the skin and leave the penis sticky.The complainant alleged that a warm wash cloth was used before trying to remove and it would not work.The patient experienced pain and discomfort with removal of the catheter.The catheter was allegedly in place for 12-24 hrs.
 
Event Description
It was reported that the catheter was difficult to unroll; the catheter would pull on the skin and leave the penis sticky.The complainant alleged that a warm wash cloth was used before trying to remove and it would not work.The patient experienced pain and discomfort with removal of the catheter.The catheter was allegedly in place for 12-24 hrs.
 
Manufacturer Narrative
The reported event was unconfirmed.Received 5 unopened spirit mecs for evaluation.The samples were visually inspected for holes or damage on the package, legibility of printed numbers and letters, expiration date, correct impression, print color, missing parts of printing, position of printing, damaged component, and foreign matter.The samples met the acceptance criteria.The samples were evaluated according to the alleged failure mode and all samples were found within specification.The acceptable peel strength must be in a range from 0.60 to 2.10 lbf.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll self-adhering catheter over penis.4) gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.5) connect to drainage device.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.".
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 36MM 30BX
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7312742
MDR Text Key101709692
Report Number1018233-2018-00665
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741070952
UDI-Public(01)00801741070952
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/28/2022
Device Model Number35304
Device Catalogue Number35304
Device Lot NumberJUBR0862
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Date Manufacturer Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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