MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER

Catalog Number	46490
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).
Event or Problem Description
An end user reported an issue with a bioflo midline 5f dl-20cm max sterile barrier drape kit w/ two nitinol guidewires.It was reported that approximately 12 hours after the midline placement, the line was noted to be leaking at the catheter connection, with dual split.The line was removed and replaced bedside with a new of the same device.The second device was infused with no issues for the remainder of the patient's stay, approximately 48 hours.It was reported that there was a slight delay in the administration of a scheduled antibiotic due to the original line leaking, however this was able to be rescheduled by pharmacy once a new line was inserted and effective care was given.The patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of midline device leaked at the junction of the extension leg tubing and the hub bifurcation cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (dfu), that is supplied in the reported kit contains information for the end user to reference in order to maintain the integrity of the catheter.The information that is provided includes, but is not limited to the following precautions and warnings: do not use if sterile barrier is damaged.If damage is found, call your navilyst medical representative.Inspect prior to use to verify that no damage has occurred during shipping.Do not use if package is opened or damaged.Do not fully insert catheter up to suture wing.Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.It is recommended that only luer lock accessories be used with the bioflo picc 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.Catheter removal: 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.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).

• Brand Name: BIOFLO MIDLINE
• Common Device Name: 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: 16233059
• Report Number: 1317056-2023-00009
• Device Sequence Number: 15050551
• Product Code: FOZ
• UDI-Device Identifier: H965464901
• UDI-Public: H965464901
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 46490
• Device Lot Number: 5763984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 58 KG