MAUDE Adverse Event Report: SPECTRUM VASCULAR BIOFLO 4F SL 55CM MST-70 KIT VALVED PG; PERIPHERALLY INSERTED CENTRAL CATHETER,

Catalog Number	H965458120
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A uk distributor reported an issue with a bio-flo 4f sl 55cm mst-70 kit valved pg.It was reported that the picc coiled and kinked in the patient's arm.The picc line had to be removed and a new picc had to be inserted.
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 catheter tip malposition with subsequent coiling and kinking was confirmed via review of an image provided by the distributor.If the complaint sample is received and warrants further investigation, then the complaint file will be reopened and updated accordingly.A dhr review of the packaging/assembly/valve lots was conducted for any deviations related to the reported catheter malposition failure mode.The review confirmed that the lots met all material, assembly and performance specifications with no internal non-conformance reports (ncr) written.The most likely root cause of the reported event is attributable to use-related factors, specifically either forceful/incorrect flushing technique or patient movement resulting in catheter tip displacement.The event remains consistent with known risks associated with catheter placement, patient physiology, and use conditions, and does not indicate a new hazard or hazardous situation.Labeling review: labeling review was performed.The dfu addresses the reported failure mode and provides appropriate guidance.The dfu that is supplied with the product (16600224-01) contains the following directions and precautions: if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not fully insert catheter up to suture wing.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion.Do not place the catheter into the right atrium or the right ventricle of the heart avoid sharp or acute angles during insertion which may compromise catheter functionality.If placing catheter at patient bedside turn patient's head toward insertion side with chin to shoulder.Slowly and incrementally, insert catheter assembly through the peelable sheath to desired tip location.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 4F SL 55CM MST-70 KIT VALVED 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: 25211761
• Report Number: 3030714660-2026-00005
• Device Sequence Number: 10565355
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: H965458120
• Device Lot Number: 5852646
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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