MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® HYDRO-GLIDE¿ GUIDEWIRE

Model Number	145FS35
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that purple coating color of the guidewire was peeling and could be seen under endoscopy.Stated that the user was exposed to hazardous, blood, or bodily fluids.The user needed to reinsert a new guidewire.It was unknown what medical intervention was provided.
Event or Problem Description
It was reported that purple coating color of the guidewire was peeling and could be seen under endoscopy.Stated that the user was exposed to hazardous, blood, or bodily fluids.The user needed to reinsert a new guidewire.It was unknown what medical intervention was provided.Per sample evaluation notification received on 22aug2023, stated that the guidewire was found to be exposed during the sample evaluation.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for patient treatment.The product had not caused the reported failure.Received 6 opened hydro-glide guide wires without packaging.Visual inspection noted the guidewire wire exposed on the 1st guide wire.Microscopic visual observation: samples were observed under microscope at 15x and 30x respectively and noted clear flaking at different points on each guide wire and this observed "flaking" was most likely in reference to the clear silicon like material on the outside.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.The reported event is unconfirmed a labeling review is not required.Section a through f - the information provided by bd represents all 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: BARD® HYDRO-GLIDE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16918309
• Report Number: 1018233-2023-03345
• Device Sequence Number: 20513180
• Product Code: EZB
• UDI-Device Identifier: 00801741053252
• UDI-Public: (01)00801741053252
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 145FS35
• Device Catalogue Number: 145FS35
• Device Lot Number: GFGR1887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown