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

Model Number 165816

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the sterilization method on the package of silicone foley catheter was not matching with the foil.It was noted that the label on the box was mentioned as biocath, the article number on the label was 165816 however the article number on the inner packaging label denoted as 165816ce - all silicone catheter.

Event Description

It was reported that the sterilization method on the package of silicone foley catheter was not matching with the foil.It was noted that the label on the box was mentioned as biocath, the article number on the label was 165816 however the article number on the inner packaging label denoted as 165816ce - all silicone catheter.Per mail notification received via ibc on 11oct2021, stated that this complaint has been returned to mediq.It is part of parallel purchasing.This item, with this lot number, was never purchased through bdi.Catheter has been repackaged by an external company.They made a mistake with repacking and relabeling.Regulatory is notified and further steps will be taken if necessary.

Manufacturer Narrative

The reported event was confirmed- observation found that there was error on the labelling of cardboard sleeve versus pouch printed label based on attached photo.Observed ¿repack¿ evidences on the complaint photos.Further information indicated this complaint unit has been repackaged by an external company.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 silicone.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.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.For urological use only.Do not use if package is damaged.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.Female use only refer to direct unit label for product content and gender specific use where applicable.Caution: consult accompanying documents.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Refer to direct unit label for sterilization method utilized sterilized by radiation sterilized by ethylene oxide" the actual/suspected device was evaluated.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: 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: 12584637
• MDR Text Key: 275006290
• Report Number: 1018233-2021-06258
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: MYEZ1531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other