MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER SILICONE COATED; FOLEY CATHETER (SILICONE)

Model Number	123522A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the foley catheters leaked.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could be user related (example: contact with sharp object/mechanical failure/operator error/thin rubberize layer).The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: do not use the product of have later allergy.Scope of application: foley catheter is intended for use in the drainage of urine from the bladder of children and adults.Precaution: this product contains natural rubber latex which may cause allergic reaction.Sterile unless package has been opened or damage.Warning: do not use petroleum substrate lubricants with the latex- based urethral catheters such as petroleum jelly and label liquid paraffin, which will damage latex and may burst balloon.Water-soluble lubricant can be used.Storage: catheters need to be stored at room temperature and keep away from the direct light and preferably stored in the original packing box.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the foley catheters leaked.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12252745
• Report Number: 1018233-2021-04638
• Device Sequence Number: 4950598
• Product Code: EZC
• UDI-Device Identifier: 00801741095122
• UDI-Public: (01)00801741095122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 123522A
• Device Catalogue Number: 123522A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other