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

Model Number	33614
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
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 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.
Event or Problem Description
It was reported that black spots were present in the product.
Additional Manufacturer Narrative
The reported issue ( black spots were found in the product.Sealed samples are sent not open from your packaging) was confirmed.During the visual inspection of the 3 samples, it was noticed that black stains were at the tip of catheters.The samples were received in their package closed.The stains material were removed from the catheters with and alcohol wet towel.The foreign material exceeded its specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states 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 single use do not resterilize 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.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.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.".
Event or Problem Description
It was reported that black spots were present in the product.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: SILASTIC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7330322
• Report Number: 1018233-2018-00749
• Device Sequence Number: 8707
• Product Code: EZL
• UDI-Device Identifier: 00801741020056
• UDI-Public: (01)00801741020056
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: Other
• Device Expiration Date: 05/31/2019
• Device Model Number: 33614
• Device Catalogue Number: 33614
• Device Lot Number: NGBT0570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1