MAUDE Adverse Event Report: SPECTRUM VASCULAR BIO-FLO 4F SL-55CM CATHETER KIT VALVED PG; PERIPHERALLY INSERTED CATHETER

Catalog Number	H965458110
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A new zealand distributor reported an issue with bio-flo 4f sl-55cm catheter kit valved pg.It was reported that during clinical use, fluid leakage was observed from the external portion of the catheter tubing.Upon closer inspection, a pinhole was discovered in the tubing near the securacath stabilization device.Due to the loss of line integrity, the device was removed earlier than the scheduled treatment plan required.There was no reported patient injury or harm associated with this incident.
Additional Manufacturer Narrative
The customer's reported complaint description of a hole in catheter could not be confirmed from a visual inspection of the product as no pictures were available from the customer.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 lot met all specifications for release of product.Labeling review: the dfu that is supplied with the product (16600227-01) contains the following precautions and warnings: precautions: do not use sharp objects to open package as damage to the device may occur.If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Do not use sharp instruments near the extension tubes or catheter shaft.Catheter maintenance general catheter care and use: do not use clamps, or instruments with teeth or sharp edges on the catheter, as catheter damage may occur.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: BIO-FLO 4F SL-55CM CATHETER KIT VALVED PG
• Common Device Name: PERIPHERALLY INSERTED 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: 25678442
• Report Number: 3030714660-2026-00012
• Device Sequence Number: 13189343
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 07/02/2026

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: H965458110
• Device Lot Number: 5842352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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