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

Model Number	806516
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2021
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.The device was not returned.
Event or Problem Description
It was reported that the silicone foley catheter had came out from patient on (b)(6) 2021, as it was installed on (b)(6) 2021 with 10 ml sterile water.Customer further stated that the customer even pulled it back against the bladder wall to ascertain it was firmly in place.Per follow up on 19apr2021, customer stated that the balloon was totally deflated on exit.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and was allowed to rest for 30 minutes with no observed leaks.The catheter balloon was passively deflated with no issues or cuffing noted, and the balloon concentricity was observed to be 70:30 as compared.This meet specification per inspection procedure, which states, "cuts in lumens are not allowed".No root cause could be found because the reported event was unconfirmed.The device history record and labeling review was not required as the reported event was unconfirmed.Corrections: d, 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 or Problem Description
It was reported that the silicone foley catheter had come out from patient on (b)(6) 2021, as it was installed on (b)(6) 2021 with 10 ml sterile water.Customer further stated that the customer even pulled it back against the bladder wall to ascertain it was firmly in place.Per follow up on (b)(6) 2021, customer stated that the balloon was totally deflated on exit.

• Brand Name: BARDIA® ALL-SILICONE 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: 11812370
• Report Number: 1018233-2021-02735
• Device Sequence Number: 19623277
• Product Code: EZL
• UDI-Device Identifier: 00801741039171
• UDI-Public: (01)00801741039171
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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): 10/26/2021

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 Expiration Date: 08/31/2024
• Device Model Number: 806516
• Device Catalogue Number: 806516
• Device Lot Number: NGDZ3348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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: Male