MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of refy1175 showed three other similar product complaint(s) from this batch number.The complaints for this batch number have been reported from the same facility in belgium.

Event Description

It was reported by the customer that the catheter was blocked with the guidewire, while in the patient's vein.No other information was provided.

Event Description

It was reported by the customer that the catheter was blocked with the guidewire, while in the patient's vein.Additional information received: the event did not involve an urgent/life threatening medical situation.The wire did not break into multiple pieces, no fragments were left in the patient, wire was completely removed intact.Small skin incision was made to retrieve catheter and guidewire stuck in subcutaneous tissue.

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 available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged midline catheter was confirmed.The product returned for evaluation was one 22ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The guidewire was advanced to the locked position.A complete break was observed in the catheter shaft approximately 3cm from the molded joint.The distal catheter fragment was bunched and adhered to the distal end of the guidewire.Microscopic inspection of the catheter confirmed abundant deformation at the break site.Inspection of the break site revealed a partially gloss and partially granular fracture surface.A longitudinally aligned scoring mark was observed on the inside surface leading into the fracture site.Inspection of the distal end of the catheter revealed abundant deformation.Inspection of the guidewire revealed it to be intact; however, deformation and coil misalignment were observed near the coil/core transition.Inspection of the needle revealed deformation along the proximal edge of the bevel.The guidewire bend and catheter tip deformation were consistent with attempted insertion against resistance, such as into tissue.The wire coil misalignment, needle bevel deformation and catheter fracture features were consistent with damage caused by retraction of the wire and catheter against the needle bevel.It appeared that resistance was encountered during initial device insertion/advancement and subsequent retraction caused multiple instances of device damage.H3 other text : evaluation findings are in section h.11.

• Brand Name: 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16440814
• MDR Text Key: 310255700
• Report Number: 3006260740-2023-00554
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 6F122080
• Device Lot Number: REFY1175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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