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

Model Number	N/A
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported trying to put in midline but nurse unable to separate the line and needle.Unknown if patient was harmed.There was patient impact, midline could not be inserted and procedure was cancelled.The problem occurred with the flexible end of the guidewire, it got caught on the end of the insertion needle bevel and could not be removed or advanced.No other information was provided.07/03/2024 - the guidewire returned for evaluation exhibited a kink.
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 difficult insertion of a guidewire through a needle is inconclusive because the needle was not returned for evaluation.One 0.018 in.X 50 cm.Nitinol guidewire was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned guidewire.A small kink was observed at the proximal end of the guidewire.A functional test of attempting to insert the complainant guidewire into a non-complainant 21 ga introducer needle revealed the guidewire passed through the introducer needle with no resistance.A microscopic observation revealed nothing remarkable along the guidewire.No misaligned coils were observed throughout the complainant guidewire.No excessive use residues were observed throughout the returned guidewire.Because the needle was not returned for evaluation, the complaint of difficulty passing a guidewire through a needle is inconclusive.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: 4FR DL POWERMIDLINE MAX 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19837644
• Report Number: 3006260740-2024-04072
• Device Sequence Number: 12716740
• Product Code: PND
• UDI-Device Identifier: 00801741129353
• UDI-Public: (01)00801741129353
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• 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
• Report Date (Section B): 07/15/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: P4254108D
• Device Lot Number: REHW2058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: Other
• Patient Sex: Unknown