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

Model Number	123626A
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
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.
Event or Problem Description
It was reported that new material code of bardia foley catheters did not have color coding on the packaging of the box and also the wordings on the individual sterile packaging was too small.Per follow-up information received from ibc on 16jun2022, confirmed that one more lot number of bardia foley catheters did not have color coding on the packaging of the box and the wordings on the individual sterile packaging was too small based on the photo sample received on 09jun2022.
Event or Problem Description
It was reported that new material code of bardia foley catheters did not have color coding on the packaging of the box and also the wordings on the individual sterile packaging was too small.Per follow-up information received from ibc on 16jun2022, confirmed that one more lot number of bardia foley catheters did not have color coding on the packaging of the box and the wordings on the individual sterile packaging was too small based on the photo sample received on 09jun2022.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.Based on the attached photo, there was no photo of dispenser box provided and attached for that related item.The reported event was inconclusive as no sample has been returned and no evidence on mislabel issue can be confirmed.A potential root cause for this failure could be operator handling method or failed 1st printed label verification on pouch paper which leading to mislabeling.A potential root cause for this failure mode could be due to operator handling method or failed 1st printed label verification on pouch paper which leading to mislabeling.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: caution: this product contains natural rubber latex which may cause allergic reactions.Sterile: unless package has been opened or damaged.Warning: do not use ointments or lubricants having a petroleum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.Single use only.Do not desterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.\ the actual/suspected device was inspected.

• Brand Name: BARDEX® FOLEY CATHETER SILICONE COATED
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14852895
• Report Number: 1018233-2022-04995
• Device Sequence Number: 5219497
• Product Code: KOD
• UDI-Device Identifier: 00801741095245
• UDI-Public: (01)00801741095245
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 123626A
• Device Catalogue Number: 0167V16S
• Device Lot Number: MYCRRC36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• 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