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

Model Number	45883
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint reference: (b)(4).
Event or Problem Description
Bioflo picc # 2: a cancer care clinical nurse consultant reported 2 occurrences of bioflo piccs fracturing at the hub to an msa territory manager.It is believed that the hubs may have fractured due to overtightening of the "bungs (needleless connectors).The picc was removed and replaced with a new of the same device.There was no harm of injury to the patient due to this event.It was indicated the reported device is available for return to the manufaturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 5f dl bioflo picc.As received, the catheter was trimmed to approximately 40cm mark.The returned bioflo picc appeared used.The dl bioflo picc was returned with caps attached to each luer.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 valve or catheter.The customer's complaint description is confirmed for cracked hub luer.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 ship 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 item number {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.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.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.Complaint 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
• MDR Report Key: 10387989
• Report Number: 1317056-2020-00135
• Device Sequence Number: 16847436
• Product Code: LJS
• UDI-Device Identifier: H965458830
• UDI-Public: H965458830
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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 Model Number: 45883
• Device Catalogue Number: 45883
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1