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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 32MM 30BX
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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 32MM 30BX Back to Search Results
Catalog Number 35303
Device Problems Difficult to Remove (1528); Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2017
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 adhesive was so strong, the patient allegedly, could not remove the catheter.The patient allegedly could not use another catheter because of skin abrasions; however, no medical intervention was reported.
 
Manufacturer Narrative
The reported event was unconfirmed.Three samples were received for review.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.Per the functional evaluation, the samples were evaluated according to the alleged failure mode: "strong adhesive" and all samples were found within specification.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: wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Unroll self-adhering catheter over penis.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.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.".
 
Event Description
It was reported that the adhesive was so strong, the patient allegedly, could not remove the catheter.The patient allegedly could not use another catheter because of skin abrasions; however, no medical intervention was reported.
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 32MM 30BX
Type of Device
MEC
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6299002
MDR Text Key66661673
Report Number1018233-2017-00294
Device Sequence Number1
Product Code NNX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other,us
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/31/2020
Device Catalogue Number35303
Device Lot NumberNGZK1549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age60 YR
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