MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FRENCH SILASTIC, 22CH, 30ML; SILASTIC FOLEY CATHETER

Model Number	33422
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 male end that connects to the urinary bag.
Additional Manufacturer Narrative
Received 1 unopened silastic foley catheter.The reported event was confirmed as use related.The sample was 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.The reported condition could not be attributed to a manufacturing-related process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state 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 male end that connects to the urinary bag.

• Brand Name: FRENCH SILASTIC, 22CH, 30ML
• Common Device Name: SILASTIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6512251
• Report Number: 1018233-2017-01967
• Device Sequence Number: 739274
• Product Code: EZL
• UDI-Device Identifier: 00801741020018
• UDI-Public: (01)00801741020018
• 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): 10/05/2017

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 Expiration Date: 06/30/2018
• Device Model Number: 33422
• Device Catalogue Number: 33422
• Device Lot Number: LN3137
• 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: 09/29/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1