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

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 07/05/2023

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 by customer that attempted to place single lumen 4 fr midline catheter in left upper arm in left basilic vein using ultrasound guidance and 1.5cm depth needle guide.Established blood return but could not wire.The wire and needle were removed.Attempted to access same vein using 1 cm needle guide.Appeared to be in vessel with the needle and had brisk blood return.Wire inserted part way and resistance was met.Removed needle over wire as wire was not able to be easily removed with needle simultaneously.Wire needed some force in order to be removed from patient.Wire immediately inspected and found to have a knot at its tip.Procedure aborted.Patient notified.Covering provider notified and was notified to obtain imaging of lue to look for any wire fragments possibly left behind.Provider asked if we should try to obtain midline on contralateral side as patient has no iv access at this time.Provider instructed picc team to try for midline on right arm.Patient agreeable to this.Right midline successfully placed in rue.Limb alert bracelet left in place on lue until imaging completed and any fragments have been ruled out.Knotted wire lined up with new, unused wire from new kit to compare length.Tiny discrepancy in length but unable to determine if knot undone if that would account for the missing length.

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 this information, the following was concluded: the complaint of a knotted guidewire is confirmed and was determined to be use related.The product returned for evaluation was a 0.018¿ nitinol guidewire.Use residue was observed on the guidewire.Curved shape memory was observed near the distal portion of the guidewire.A knot was observed at the distal end of the guidewire.Microscopic evaluation revealed the guidewire was intact and it was confirmed there was a knot at the distal tip of the guidewire.The features were consistent with the guidewire becoming knotted during insertion.Guidewire knots have been replicated by insertion against resistance with a twisting motion prior to withdrawal.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

Event Description

It was reported by customer that attempted to place single lumen 4 fr midline catheter in left upper arm in left basilic vein using ultrasound guidance and 1.5cm depth needle guide.Established blood return but could not wire.The wire and needle were removed.Attempted to access same vein using 1 cm needle guide.Appeared to be in vessel with the needle and had brisk blood return.Wire inserted part way and resistance was met.Removed needle over wire as wire was not able to be easily removed with needle simultaneously.Wire needed some force in order to be removed from patient.Wire immediately inspected and found to have a knot at its tip.Procedure aborted.Patient notified.Covering provider notified and was notified to obtain imaging of lue to look for any wire fragments possibly left behind.Provider asked if we should try to obtain midline on contralateral side as patient has no iv access at this time.Provider instructed picc team to try for midline on right arm.Patient agreeable to this.Right midline successfully placed in rue.Limb alert bracelet left in place on lue until imaging completed and any fragments have been ruled out.Knotted wire lined up with new, unused wire from new kit to compare length.Tiny discrepancy in length but unable to determine if knot undone if that would account for the missing length.

• 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: 17439970
• MDR Text Key: 320256493
• Report Number: 3006260740-2023-03279
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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: P4154108D
• Device Lot Number: REHN1456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• 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