MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER

Model Number	70516SI
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had fall out in the second foley catheter and balloons were falling out.Nurses confirmed 10cc was going into balloon.Patient had changed own catheter balloons which were deflating about every two weeks including the one placed by the mayo hospital the third port did not have a plug that fit properly the plug we have did not fit.Patient also stated that the yellow plugs were to big for third port on whole that did not went into the port whole all the way but only about a quarter inch into the port, while patient was sleeping the plug fell out allot causing the patient come wet.Patient needed a three port for taking urine samples.Patient also stated that the catheter were to long for women who wear dresses so patient was cutting extender.Patient could not feel when they were starting to deflate they were deflating in the middle of the night.Patient was waking up wet it was falling out.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was 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.The potential root cause for this failure 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.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Common Device Name: FOLEY 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14591765
• Report Number: 1018233-2022-04352
• Device Sequence Number: 2098159
• Product Code: EZC
• UDI-Device Identifier: 00801741025433
• UDI-Public: (01)00801741025433
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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: 70516SI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown