MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

Model Number	70516SI
Medical Device Problem Codes	Incorrect Measurement (1383); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
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.The device was not returned.
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 were deflating about every two weeks including the one placed by the (b)(6) 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 whole they did not went into the port whole all the way 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.
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 were deflating about every two weeks including the one placed by the (b)(6) 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 whole they did not went into the port whole all the way 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.Per additional information received via follow up on 01jun2022, it was stated that the foley catheter was recently changed and was having no issues at this moment.Per additional information received via liberator on 08jun2022, it was stated that the another one of foleys leaked at the seam.
Additional Manufacturer Narrative
Upon further review, bd has determined this event is not reportable.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 device was not returned.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14547928
• Report Number: 1018233-2022-04227
• Device Sequence Number: 5158101
• Product Code: MJC
• 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: EXEMPT
• 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,Followup
• Report Date (Section B): 08/17/2022
• 2 Devices were Involved in the Event: 1 2

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
• Device Catalogue 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
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/18/2022
• 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