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

Model Number N/A

Device Problem Material Frayed (1262)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported by customer that while attempting to remove the guidewire through the needle, the guidewire became lodged within the vessel.The nurse was able to remove the needle and guidewire altogether, however the guidewire appears to have unraveled approximately 15-20 cm from the tip.Additional information received (b)(6)2023: while attempting to place a midline catheter, the nurse attempted to remove the guidewire through the needle and the guidewire became lodged within the vessel.The nurse was able to remove the guidewire with the needle at the same time, however the guidewire appears to have unraveled approximately 15-20cm from the tip.The nurse stopped the procedure immediately and segregated the device.The physician was notified of the issue and an x-ray was ordered to check for any retained pieces of the device.The x-ray showed no evidence of a foreign body, and the patient required no other treatment related to the event.There was no adverse outcome for this patient.

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 device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by customer that while attempting to remove the guidewire through the needle, the guidewire became lodged within the vessel.The nurse was able to remove the needle and guidewire altogether, however the guidewire appears to have unraveled approximately 15-20 cm from the tip.Additional information received 06/26/2023: while attempting to place a midline catheter, the nurse attempted to remove the guidewire through the needle and the guidewire became lodged within the vessel.The nurse was able to remove the guidewire with the needle at the same time, however the guidewire appears to have unraveled approximately 15-20cm from the tip.The nurse stopped the procedure immediately and segregated the device.The physician was notified of the issue and an x-ray was ordered to check for any retained pieces of the device.The x-ray showed no evidence of a foreign body, and the patient required no other treatment related to the event.There was no adverse outcome for this patient.

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.Based on a review of applicable information, the following was concluded: the complaint of an unraveled guidewire was confirmed and the cause appeared to be associated with use.One 0.018¿ x 50cm flexura guidewire was provided for investigation.The core wire broke 3mm from the weld tip and the coil wire was stretched over the core wire.A piece of biological material was attached to the coil wire near the weld tip, which indicates that the guidewire was likely lodged within the needle with the biological material.It was reported that the guidewire became lodged within the vessel, which can occur if the guidewire is retracted through the needle.The instructions for use (ifu) caution, ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored as part of ongoing efforts to identify potential manufacturing related issues and emerging trends.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17312874
• MDR Text Key: 319679677
• Report Number: 3006260740-2023-02902
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: S4153108D
• Device Lot Number: REGZ2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White