MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number 75063

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

It was reported from a tech that they had a picc from a tandem bioflo picc (v) 5fdl-55cm maximal barrier nursing kit w nit and df drape kit that was leaking from crack in purple lumen.The vat was notified on 03/08/2023 that one of the lumens was leaking.On assessment, the purple lumen was cracked just below where the needless connector connects to the lumen.It was difficult to see, visually, unless needless connector is screwed in just right, but when saline is hooked up, it sprays out of the lumen, showing indeed there is a crack.The last time vat assessed the line was on 03/06/2023 and there were no issues at that time.Since 03/06/2023 the patient was only on 2 iv meds that were compatible, so they could have been just using one lumen.When asked to assess on 03/08/2023, her infusions were connected to the grey lumen.And it was the patient who noted she felt wet when the bedside rn assessed the device.The rn didn't notice until patient asked where the wetness was coming from.The patient has been intermittently confused and lethargic.The reporting tech was unsure exactly when the crack happened (just that it had to be between 03/06/2023 and 03/08/2023), and what/if bedside nursing did to crack the line.The picc was originally placed 02/27/2023.The line was pulled on 03/09/2023.The picc was not replaced.The patient had no complications from this occurrence.

Manufacturer Narrative

Returned for evaluation was one (1) 5f sl bioflo picc.As received, the female luer lock component of the purple valve was confirmed to be cracked just adjacent to the parting line.There were no other visual defects noted to the valve.The customer's complaint description is confirmed for hub cracked.No component molding non-conformances or other damage was observed during visual inspection of the returned sample.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).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 pasv valve luer hub while making a connection with the nc.Grasping the pasv valve hub while connecting a syringe/tubing set to the nc can transmit additional torque to the pasv female luer hub.Inadequate flushing of the device lumen may also be a contributing factor.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the dfu that is supplied in bioflo kits 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 the angiodynamics 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).

• Brand Name: BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16662510
• MDR Text Key: 313428175
• Report Number: 1317056-2023-00036
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H965750631
• UDI-Public: H965750631
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 75063
• Device Lot Number: 5764947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female