MAUDE Adverse Event Report: SPECTRUM VASCULAR BIOFLO PICC (VALVED) 4F SL 55CM IR-145 KIT WITH NITINOL GW PG; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965458810
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a bioflo picc (valved) 4f sl 55cm ir-145 kit with nitinol gw pg when attaching a syringe for flushing.A crack was observed at the hub prior to flushing, and no flushing was performed.The affected device had to be removed and replaced with a different product.The patient did not experience any adverse effects or harm because 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 picc hub crack could not be confirmed from a visual inspection as no picture of the device was provided by the customer.If complaint sample is received and warrants further investigation, then 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 hub crack 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 for the cracked female valve housing is due to an over tightened connection with a mating male luer (likely a needleless connector) and/or inadequate flushing.A contributing factor to the over-tightened connection 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 (16600224-01) contains the following statements: precautions it is recommended that only luer lock accessories be used with the bioflo¿ picc with endexo¿ and pasv¿ valve technology.Repeated over-tightening may reduce hub connector life.Do not use hemostats to secure or remove devices with luer lock hub connections.Flushing - recommended procedure 1.Flush the catheter after every use, or at least every seven days when not in use, to maintain patency.Use a 10 ml syringe or larger.2.Flush the catheter with a minimum of 10 ml of sterile normal saline, using a "pulse" or "stop/start" technique.Warning: if using bacteriostatic saline, do not exceed 30ml in a 24-hour period.3.Disconnect the syringe and attach a sterile end cap to each luer lock hub.Note: this is the recommended flush procedure for this catheter.If using a different procedure than listed above, the use of heparin may be necessary.Follow institutional protocol for catheter flushing.Precaution: incompatible drug delivery within the same lumen may cause precipitation.Ensure that the catheter lumen is flushed following each infusion.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: place a cap on the hub after use to reduce the risk of contamination.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 cf-80.

• Brand Name: BIOFLO PICC (VALVED) 4F SL 55CM IR-145 KIT WITH NITINOL GW 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: 25104867
• Report Number: 3030714660-2026-00004
• Device Sequence Number: 10745326
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: H965458810
• Device Lot Number: 5845260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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: Required Intervention
• Patient Sex: Unknown