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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER Back to Search Results
Model Number 36303
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2022
Event Type  malfunction  
Event Description
It was reported that the 90 percentage of male external catheters would not stick.Patient stated that any movement would make the catheters peel off and no sense of adhesion at all (lot#jufz9068).Per additional information from cardinal health, it was reported that one in every few of the male external catheters were not sticking due to adhesive.Per sample received on 18oct2022, an additional lot was returned lot# jufz9067.Per investigator notification on 26oct2022, it was reported that strong adhesive was found during sample evaluation.The affected lots were jufz9068 and jufz9067.
 
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.
 
Manufacturer Narrative
The reported event is confirmed as manufacturing related.Although an exact root cause could not be determined a potential root cause could be operator error.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as labeling would not prevent the reported event.Correction: h h11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
 
Event Description
It was reported that the 90 percentage of male external catheters would not stick.Patient stated that any movement would make the catheters peel off and no sense of adhesion at all (lot#jufz9068).Per additional information from cardinal health, it was reported that one in every few of the male external catheters were not sticking due to adhesive.Per sample received on 18oct2022, an additional lot was returned lot# jufz9067.Per investigator notification on 26oct2022, it was reported that strong adhesive was found during sample evaluation.The affected lots were jufz9068 and jufz9067.
 
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Brand Name
WIDEBAND¿ SELF-ADHERING 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 Key15752084
MDR Text Key307569511
Report Number1018233-2022-08550
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741071065
UDI-Public(01)00801741071065
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 12/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number36303
Device Catalogue Number36303
Device Lot NumberJUFZ9067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2021
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 Outcome(s) Other;
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