MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 3FR SL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz3285 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "had a guide wire for a midline get stuck today.The patient is now going to ir to see if they can get it out.As soon as i met resistance, i tried to pull back on the wire, but it wouldn't budge.So then i tried to pull the wire and needle out together.The needle came out, but the wire stayed in.We measured, and it appears to be 1.5cm that got stuck in the patient's arm." additional information received 05/13/2022: "attempted to place midline to left brachial vein.Vein accessed without difficulty, however, resistance was met when inserting guide wire after about 10cm of insertion.Attempted to remove guide wire, but it became stuck.So an attempt was made to remove the guide wire with the needle, but guide wire remained stuck.Needle removed successfully.Rn (vat pcc) called for assistance.He also tried to remove guide wire as well, but was also unsuccessful.Measured external length of stuck guide wire and compared to an unused guide wire, and it appears to be 1.5cm that was stuck in pt's arm.Dr.Notified.Orders received for pt to go to ir to attempt guide wire removal.Report called to ir.They state they currently have a pt on the table.Guide wire stabilized with gauze, tape, and coban.Pt instructed to keep arm still and of the situation.Understanding verbalized.20g piv started to right forearm for iv access.Spoke to ir after wire was removed.They did not save the wire, however, they stated that the wire had a small knot on the end of it.".

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14465383
• Report Number: 3006260740-2022-01884
• Device Sequence Number: 4507060
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: REFZ3285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 94 KG