MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recx3100 showed no other similar product complaint(s) from this lot number.Device not yet returned.

Event Description

It was reported "that the patient carrying a midline connected to a perfusion parenteral nutrition came back from his examination in radiology with its midline cut.The fitting at the end of the extension of the midline was disconnected from the extension tube.The midline was not used during radiology exams.Consequences for the patient: none in the short term, the midline has been replaced.But risk of open peripheral venous route and embolism potential gas.".

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached luer connector was confirmed; however, the root cause was not identified.The product returned for evaluation was one 4fr s/l powermidline midline catheter.Usage residues were observed throughout the sample.The luer adapter was detached from the extension tubing.The extension tubing exhibited multiple regions of curved shape memory along its length.Microscopic inspection of the sample confirmed regions of cured shape memory and material necking along the length of the extension tubing.The product returned for evaluation was one 4fr s/l powermidline midline catheter.Usage residues were observed throughout the sample.The luer adapter was detached from the extension tubing.The extension tubing exhibited multiple regions of curved shape memory along its length.Microscopic inspection of the sample confirmed regions of cured shape memory and material necking along the length of the extension tubing.An attempt to detach the luer connector of a non-complainant device through pulling stress was unsuccessful.The curved shape memory, material necking and tensile weakness were consistent with damaged caused by tensile (pulling) stress; however, the inability to replicate the failure suggested that an additional unidentified factor(s) contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of recx3100 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "that the patient carrying a midline connected to a perfusion parenteral nutrition came back from his examination in radiology with its midline cut.The fitting at the end of the extension of the midline was disconnected from the extension tube.The midline was not used during radiology exams.Consequences for the patient: none in the short term, the midline has been replaced.But risk of open peripheral venous route and embolism potential gas.".

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8524419
• MDR Text Key: 142383017
• Report Number: 3006260740-2019-00897
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141034
• UDI-Public: (01)00801741141034
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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: P6154118
• Device Lot Number: RECX3100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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