MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE FULL KIT; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer that a guidewire failure/breakage that occurred this week.Ref: (b)(4), lot: rehy1089.All components were safely removed from the patient intact but broken.It appears to be more of an unwinding of the atraumatic tip after possibly be severed or sheared from contact with the needle tip.No adverse medical events or serious injury as a result of this.No other information was provided.
Additional Manufacturer Narrative
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.The complaint of a break in the guidewire is confirmed but the exact cause could not be determined.One photograph of a guidewire was returned for evaluation.An initial visual observation of the photograph showed two pieces of a guidewire on a blue drape next to its lot sticker.The guidewire was observed to be broken into one larger fragment and one smaller fragment.The smaller fragment appeared to have a long section of what appeared to be coil wire coming off one end the fragment.Characteristics of the guidewire break could not be seen in the returned photograph; therefore, the complaint of a break in the guidewire is confirmed but the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that a guidewire failure/breakage that occurred this week.Ref: s4153108, lot: rehy1089.All components were safely removed from the patient intact but broken.It appears to be more of an unwinding of the atraumatic tip after possibly be severed or sheared from contact with the needle tip.No adverse medical events or serious injury as a result of this.No other information was provided.

• Brand Name: 3FR SL PROVENA MIDLINE FULL KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19198756
• Report Number: 3006260740-2024-01956
• Device Sequence Number: 8474016
• Product Code: PND
• UDI-Device Identifier: 00801741153938
• UDI-Public: (01)00801741153938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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 Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: S4153108
• Device Lot Number: REHY1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: Required Intervention
• Patient Sex: Unknown