MAUDE Adverse Event Report: SPECTRUM VASCULAR CAN 5F DL BIOFLO PASV PICC NURSING TRAY, ST. PAUL'S HOSPITAL (STP); PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H96560M7009361
Medical Device Problem Codes	Difficult to Flush (1251); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
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 difficulty flushing a catheter could not be confirmed as the picc was disposed of before a picture could be taken.A dhr review of 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.The most likely root cause of the reported event is attributable to use-related factors, including over-pressurization of the catheter tubing against an occluded lumen.The event remains consistent with known risks associated with use conditions, and does not indicate a new hazard or hazardous situation.Labeling review was performed.The dfu addresses the reported failure mode and provides appropriate guidance.The dfu that is supplied with the product (14600124-01) contains the following directions and precautions: warnings: failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.Power injector's pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter.Exceeding the maximum allowable flow rate (table 2) may result in catheter failure and/or catheter tip displacement.The maximum pressure of power injectors used with the power injectable picc must not exceed 325 psi (2,240 kpa).Precaution: if resistance is met when flushing, it is recommended that no further attempts be made.Further flushing may result in catheter rupture.Refer to institutional protocol for clearing occluded catheters.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis.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).
Event or Problem Description
A canada distributor reported an issue with a 5f dl bioflo pasv picc.It was reported that a patient experienced discomfort when flushing the grey lumen placed in the upper arm, with positional flow noted.Evaluation by the iv team found no mechanical occlusion or kinking, including review of a prior chest x-ray.During simultaneous flushing of both lumens, bulging was observed approximately 1 cm from the insertion site.The picc was removed and replaced, resulting in additional intervention and delay in treatment.

• Brand Name: CAN 5F DL BIOFLO PASV PICC NURSING TRAY, ST. PAUL'S HOSPITAL (STP)
• 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: 25323575
• Report Number: 3030714660-2026-00010
• Device Sequence Number: 14775187
• Product Code: LJS
• UDI-Device Identifier: H96560M7009361
• UDI-Public: H96560M7009361
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/29/2026

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: H96560M7009361
• Device Lot Number: 5850710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown