MAUDE Adverse Event Report: SPECTRUM VASCULAR BIOFLO PICC (NON-VALVED) 6FTL-55CM MST-70 KIT WITH NITINOL GUIDEWIRE PG; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965459680
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An australia distributor reported an issue with bioflo picc (non-valved) 6ftl-55cm mst-70 kit with nitinol guidewire pg.It was reported that an end-user experienced a hub-catheter separation during a ct test flush with saline at 3 ml/sec, below the device's rated flow.The injector alarmed for high pressure, followed by a "pop," and the purple hub was observed to have separated from the catheter.The line was immediately secured, and the patient remained stable with no signs of harm.The picc was subsequently removed.There was no report of the patient experiencing any adverse effects, or harm as a result of this incident.
Additional Manufacturer Narrative
As the reported device was not returned, a device evaluation is unable to be performed.The customer's reported complaint description of a luer detaching from the catheter could also not be confirmed from a visual inspection of the pictures sent by the customer as these showed the luer to be attached to the catheter.If complaint sample is received and warrants further investigation, then the complaint file will be reopened and updated accordingly.A review of production records for the packaging/assembly/valve lots was conducted for any deviations related to the reported failure mode.The review confirmed that the lots met all material, assembly and performance specifications with no internal non-conformance reports (ncr) written.A contributing factor to the luer detaching from the catheter 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.An instructional video regarding the care and maintenance of the bioflo picc can be found on spectrum vascular's youtube channel, "bioflo picc care and maintenance instructional video" uploaded on september 24, 2025.This video is intended as a visual representation of information provided in the dfu for clinicians who are responsible for the care and maintenance of piccs but are not responsible for picc placement.Labeling review: the dfu that is supplied with the product (16600227-01) contains the following precautions and warnings: warnings do not use if package is opened or damaged.If using bacteriostatic saline, do not exceed 30 ml in a 24-hour period.Precautions 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.Do not attempt to repair the catheter.If breaks or leaks are apparent in the catheter, remove the catheter immediately.If resistance is met while attempting to flush catheter, follow institutional protocol for occluded catheters.Flushing and heparinization 1.Attach syringe to hub, open clamp, and aspirate blood.2.Close clamp, detach syringe and discard according to institutional protocol.3.Attach syringe filled with 10 ml sterile normal saline, open clamp, and flush lumen, using a "pulse" or "stop/start" technique.Note: if flushing after a power injection, use 20 ml sterile normal saline.4.Close clamp, detach syringe and discard according to institutional protocol.5.Draw heparinized saline into syringe, and attach to hub.6.Open clamp, and inject amount equal to or greater than priming volume into lumen (see table 1).7.Maintaining positive pressure on syringe, close clamp, detach syringe and discard.Note: flush catheter after every use.When not in use, flush at least every 12 hours, or according to institutional protocol to maintain patency.Note: monitor stabilization device daily.Replace at least every seven days.A trend analysis was conducted for this complaint type and product family with no adverse trends noted.We will continue to monitor this complaint type for any adverse trends.Reference: (b)(4).

• Brand Name: BIOFLO PICC (NON-VALVED) 6FTL-55CM MST-70 KIT WITH NITINOL GUIDEWIRE PG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): SPECTRUM VASCULAR; 50 main street; suite 1000; white plains NY 10606
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: james solorzano ; 50 main street; suite 1000; white plains, NY 10606
• MDR Report Key: 25547950
• Report Number: 3030714660-2026-00011
• Device Sequence Number: 16137666
• Product Code: LJS
• UDI-Device Identifier: H965459680
• UDI-Public: H965459680
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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 Catalogue Number: H965459680
• Device Lot Number: 5850849
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown