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

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 315971518
• Report Number: 3006260740-2023-02109
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108754
• UDI-Public: (01)00801741108754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other