MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER

Catalog Number 46490

Device Problem Crack (1135)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, a picture was provided showing the purple hub is cracked.The customer's reported complaint description of picc hub cracked was confirmed with the photo provided by the customer.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The most likely root cause for the cracked female luer is due to an over tightened connection with a mating male luer (likely a needleless connector).A contributing factor to the over-tightened connection may be the mechanics/hand placement during infusion access.It is preferable to grasp the needleless connector (nc) when connecting a syringe/tubing to it rather than grasping the luer hub while making a connection with the nc.Grasping the luer hub while connecting a syringe/tubing set to the nc can transmit additional torque to the female luer hub.Inadequate flushing of the device lumen may also be a contributing factor.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the dfu that is supplied in bioflo kits item number (16600281-01) contains the following precaution: the bioflo* midline catheter with endexo* technology is a radiopaque, polyurethane catheter with luer lock hub(s), polyurethane extension tube(s) and suture wing.The catheter is available in single and dual lumen configurations.The bioflo midline is clearly labeled on all available catheter surfaces to identify as a midline versus a traditional picc.Precaution: if a needleless connector is attached to catheter hub, first ensure that it will sustain power injection.Attach power injector to selected lumen hub per manufacturer's recommendations, and open clamp.Stabilize catheter and luer lock hub during dressing removal to prevent accidental dislodgment.Separate dressing away from luer lock hub and toward insertion site.As you separate, keep any tape and dressing close to patient's arm to avoid dislodging catheter or sutures.To remove catheter, grasp catheter between suture wing and insertion site and remove slowly, in small increments, keeping catheter parallel to skin surface.Do not grasp luer lock hub to remove catheter, as catheter damage may occur.It is recommended that only luer lock accessories be used with the bioflo midline catheter with endexo technology.Repeated over-tightening may reduce hub connector life.Do not use hemostats to secure or remove devices with luer lock hub connections.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

Event Description

An end user reported an issue with a midline catheter from a bioflo midline 5f dl-20cm max sterile barrier drape kit w/ two nitinol guidewire.Nine days post procedure, it was reported the patient's midline had cracked on the hub.The midline catheter was removed and replaced.The patient did not experience any adverse effects or harm because of this incident.

• Brand Name: BIOFLO MIDLINE
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19201830
• MDR Text Key: 341992926
• Report Number: 1317056-2024-00070
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: H965464901
• UDI-Public: H965464901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46490
• Device Lot Number: 5812025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2024
• 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