MAUDE Adverse Event Report: SPECTRUM VASCULAR BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	H965750191
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was one (1) 5f dual lumen bioflo picc.As received, the catheter was cut just past the 10cm mark.The purple/ white female luer lock and purple/purple female luer lock were still connected to the needleless connector and green curos cap.Both needless connectors were extremely difficult to remove.The white female luer lock of the purple/white valve was confirmed to be cracked.The purple female luer lock of the purple/purple valve was not cracked.The customer's complaint description is confirmed for picc hub cracked.No component manufacturing/molding non-conformances or other damage was observed during visual inspection of the returned sample.A dhr review of the packaging/assembly/valve lots were reviewed for any deviations related to the reported hub crack failure mode.The review confirms 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; reference youtube video, "angiodynamics bioflo picc care and maintenance instructional video" uploaded on november 18, 2020.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 in bioflo kits item number (14600128-01) contains the following precaution: 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 30 ml 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 review of our complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
Event or Problem Description
An end user experienced an issue when using a bioflo picc (valved) 5fdl-55cm maximal barrier nursing kit.Post placement, it was noted the hub was cracked.The picc was being used for tpn.The picc required removal, it is unknown if it was replaced.The patient did not experience any adverse effects or harm because of this incident.

• Brand Name: BIOFLO PICC (VALVED) 5FDL-55CM MAXIMAL BARRIER NURSING KIT
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): SPECTRUM VASCULAR; 50 main st; ste. 1000; white plains NY 10606
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave; queensbury NY 12804
• Manufacturer Contact: james solorzano ; 50 main st; ste. 1000; white plains, NY 10606
• MDR Report Key: 21606912
• Report Number: 3030714660-2025-00005
• Device Sequence Number: 18460486
• Product Code: LJS
• UDI-Device Identifier: H965750191
• UDI-Public: H965750191
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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 Expiration Date: 02/28/2026
• Device Model Number: H965750191
• Device Lot Number: 5823660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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
• Patient Sex: Unknown