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

Model Number	33424
Health Effect - Clinical Code	No Information (3190)
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 the rubber was cracking around the rubber tubing of the inflation port.
Additional Manufacturer Narrative
Received 8 samples of lot ngqh2912 (manufacturing lot # pw542) and 2 samples of lot 76hm0766 (manufacturing lot # ar226).The reported event was confirmed as use-related.Per the visual inspection, the samples were examined and found what may be evidence of ozone damage.Factors which may contribute to this problem are storage in excessive heat or cold, or storage near fluorescent lighting, electric motors or ozone generating equipment (i.E., x-ray equipment).For this reason, latex products should not be stored in close proximity to any of these electrical devices or equipment.Such products should be stored in their original cartons with the end flaps closed, away from direct lighting and extreme temperatures and should be rotated to ensure that the oldest products are used first.Could not attribute the reported condition to a manufacturing-related process.The lot number is unknown; therefore, the device history record could not be reviewed.However, a device history record review was performed on the stock sample lots received for evaluation.The instructions for use states the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that the rubber was cracking around the rubber tubing of the inflation port.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: SILASTIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6511952
• Report Number: 1018233-2017-01965
• Device Sequence Number: 734439
• Product Code: EZL
• UDI-Device Identifier: 00801741020025
• UDI-Public: (01)00801741020025
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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 Model Number: 33424
• Device Catalogue Number: 33424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1