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

Catalog Number	33420
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
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.Udi format updated with available product information per gudid.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 revision of the foley catheter since the packaging and the invoice says expiration date 08/31/2026 and the probe says 04/30/2024.Per additional information received via ibc on 19aug2024, stated that 70 pieces arrived of which 25 pieces were sold and confirmed date of the event on 13/08/2024 that we became aware of.Only 45 pcs related to this incident available for analysis.25 pieces sold also had the same problem.
Event or Problem Description
It was reported that the revision of the foley catheter since the packaging and the invoice says expiration date 08/31/2026 and the probe says (b)(6) 2024.Per additional information received via ibc on 19aug2024, stated that (b)(4) pieces arrived of which (b)(4) pieces were sold and confirmed date of the event on (b)(6)2024 that we became aware of.Only 45 pcs related to this incident available for analysis.(b)(4) pieces sold also had the same problem.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Visual evaluation of the returned two-photo sample noted one opened box (with original packaging), silastic foley.Visual inspection of the two-photo sample shows the catheter packaging with the expiration date (30apr2024), and the packaging box expiration date as (31aug 2026).According to jde, per lot#ngjq1723 the release date: 08apr2024 and the expiration date: 31aug2026.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿wrong label put on package¿.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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.Do not use if package is damaged bard, bardex, and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use do not resterilize manufacturer: to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.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 necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Keep away from sunlight valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water do not exceed recommended capacities." udi format updated with available product information per gudid.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.

• Brand Name: BARD® SILASTIC® 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20077741
• Report Number: 1018233-2024-05217
• Device Sequence Number: 12657541
• Product Code: EZL
• UDI-Device Identifier: 00801741020001
• UDI-Public: (01)00801741020001(11)240408(17)260831(10)NGJQ1723
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 08/31/2026
• Device Catalogue Number: 33420
• Device Lot Number: NGJQ1723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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