MAUDE Adverse Event Report: SPECTRUM VASCULAR BIO-STABLE 3F SL-55CM MST-70 KIT VALVED PG; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965458020
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a picc from a bio-stable 3f sl-55cm mst-70 valved kit.The patient had the picc placed on (b)(6) 2024.It was reported post placement, that the picc hub cracked, requiring removal and replacement.The picc was removed and replaced on (b)(6) 2025.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
The reported device is not available for return to the manufacturer for a device evaluation.An investigation into the root cause for the product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a picc from a bio-stable 3f sl-55cm mst-70 valved kit.The patient had the picc placed on (b)(6) 2024.It was reported post placement, that the picc hub cracked, requiring removal and replacement.The picc was removed and replaced on january 4, 2025.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
This report is a follow up to an initial report filed february 7, 2025.As the reported device was not returned, a device evaluation is unable to be performed.Investigation was completed based on information received to date.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 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.Labeling review: the dfu that is supplied with the device (ifu: 16600224-01) 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 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 review of similar complaints noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference cf-(b)(4).

• Brand Name: BIO-STABLE 3F SL-55CM MST-70 KIT VALVED PG
• 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: 21338276
• Report Number: 3030714660-2025-00001
• Device Sequence Number: 8598505
• Product Code: LJS
• UDI-Device Identifier: H965458020
• UDI-Public: H965458020
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Catalogue Number: H965458020
• Device Lot Number: 5820059
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown