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

Model Number 0165SI18

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 foley catheter was in an unsealed package.

Event Description

It was reported that the foley catheter was in an unsealed package.

Manufacturer Narrative

The reported event was confirmed, but the cause was unknown.Visual evaluation of the returned sample noted one bardex latex foley in opened original packaging.The packaging on the end of the opening appeared to be cut.The blue sleeve and the strip pack were both torn, exposing the catheter.Based on the evaluation, it could not be determined at what point the packaging was damaged before it was received by patient.Holes/ broken/ open seals are out of specification.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: "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.Valve type: use luer slip tip syringe.Do not use needle.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: do not aspirate urine through drainage funnel.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Do not use if package is damaged.Recommended indwelling time not to exceed 28 days.Bard, bardex, and the i.C.Logo are trademarks and/or registered trademarks of c.R.Bard, inc.*bacti-guard® silver alloy coating is licensed from bactiguard ab.Bacti-guard is a registered trademark of bactiguard ab.©2014 c.R.Bard, inc.All rights reserved.Catheter made in u.S.A." section a through f - the information provided by bd 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 bd.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8359224
• MDR Text Key: 137125810
• Report Number: 1018233-2019-00933
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016769
• UDI-Public: (01)00801741016769
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 0165SI18
• Device Catalogue Number: 0165SI18
• Device Lot Number: NGAP0795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1