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

Model Number	45832
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A distributor reported an issue with a bio-stable 5f dl 55cm mst-70 kit.A patient was admitted in ae (b)(6) 2021 with haemoptysis and abdominal pain.On (b)(6) 2021 a double lumen picc was inserted for use with tpn due to gastric outlet obstruction.Post procedure, on (b)(6) 2021, a leak was noted.On (b)(6) 2021, upon closer inspection of the picc line, it was noted the white tpn lumen had a hairline fracture.The lumen was being used for administration of tpn.There was no documentation of excessive force being applied nor to the patient's recall.A bbraun caresite needlefree connector was used and was reported to be leaking, prior to assessment.After the fracture was discovered, the patient opted to keep the picc line in place until line removal upon discharge.The risks of leaving a fractured picc line in place was explained to the patient.The picc was removed on (b)(6) 2021.It was not replaced at that time.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was one dl biflo picc.As received, the female luer lock component of the white valve was confirmed to be cracked just adjacent to the parting line.There were no other visual defects noted to the purple 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.The device history records for the bioflo pasv picc packaging and picc assembly 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.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.Warn ing: 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.Angiodynamics has created 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.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
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 12086642
• Report Number: 1317056-2021-00121
• Device Sequence Number: 11730009
• Product Code: LJS
• UDI-Device Identifier: H965458320
• UDI-Public: H965458320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2021

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: 07/31/2022
• Device Model Number: 45832
• Device Catalogue Number: 45832
• Device Lot Number: 5628795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR