MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® SILICONE COATED FOLEY CATHETER; SILICONE 2-WAY CATHETER

Model Number	0165V22S
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the foley catheters were shipped in a box that was too small.The product was twisted and bent in half.They were unable to be used upon arrival.This was the 3rd occurrence.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.The potential root cause could be due to " inappropriate package design".The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not completed as the user would not likely cause this issue.H11: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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the foley catheters were shipped in a box that was too small.The product was twisted and bent in half.They were unable to be used upon arrival.This was the 3rd occurrence.

• Brand Name: BARDEX® SILICONE COATED FOLEY CATHETER
• Common Device Name: SILICONE 2-WAY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9591287
• Report Number: 1018233-2020-00292
• Device Sequence Number: 2474545
• Product Code: EZC
• UDI-Device Identifier: 00801741039423
• UDI-Public: (01)00801741039423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: Lay User/Patient
• Device Model Number: 0165V22S
• Device Catalogue Number: 0165V22S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1