MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT,4FR POWERMIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported that wire sheared before placing in patient.Additional information received the event was discovered by the person performing the procedures witnessing them in real time.No reported negative outcomes, just had to get new kits and start again.There was not a serious delay in treatment as they were not emergent line placements.The one was for de-escalating piccs per our protocol so the patient had an alternate line.I cannot recall the other patient but the only delay was going to get new kits.This file addresses the de-escalating picc per facility protocol.
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 frayed wire is confirmed but the exact cause remains unknown.One photo sample of an unraveled stylet was provided for evaluation.The core wire is not clearly visible; however, the coil wire was observed to be elongated and frayed.Based on the photo sample provided, possible contributing factors include retraction against resistance or against the needle bevel.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause.Since the guidewire was found to be frayed, the complaint is confirmed but the exact contributing factors remain unknown.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported that wire sheared before placing in patient.Additional information received: the event was discovered by the person performing the procedures witnessing them in real time.No reported negative outcomes, just had to get new kits and start again.There was not a serious delay in treatment as they were not emergent line placements.The one was for de-escalating piccs per our protocol so the patient had an alternate line.I cannot recall the other patient but the only delay was going to get new kits.This file addresses the de-escalating picc per facility protocol.

• Brand Name: DOT,4FR POWERMIDLINE
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17006671
• Report Number: 3006260740-2023-02109
• Device Sequence Number: 12607104
• Product Code: PND
• UDI-Device Identifier: 00801741108754
• UDI-Public: (01)00801741108754
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/24/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: P4154108
• Device Lot Number: REGZ2121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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