MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Catalog Number	75033
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2021
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 nurse reported an issue with a bioflo picc (nv) 5fdl-55cm maximal barrier nursing kit w/70cm nitinol wire.Post procedure, the picc was found to have "split" where there appeared to be a kink at the 6cm mark, while in the patient's arm.The patient reported some pain upon flushing, but the flushing did not cause any harm to the patient.The line was d/c'd when patient reported pain with injection.The picc was removed and was replaced with a piv.The patient only had the picc for 8 days and the nurse reported not knowing how much handling and manipulation the device had received prior to her noticing the kink and split in the catheter.There was no patient harm or adverse event 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 5f bioflo picc.As received, the 5f bioflo picc contained clear fluid.The catheter contained a flat spot and slice/hole at the 5.5 cm mark.There is a longitudinal slice in the catheter tubing near the 5 cm mark.The catheter tubing was confirmed to meet dimensional specifications.No manufacturing non-conformances were observed.Given the longitudinal nature of the slice/hole the likely root cause is over-pressurization of the catheter tubing.This can occur when infusion is attempted against a distal tip obstruction/occlusion or use of a small syringe for infusions (less than 10ml syringe).This is cautioned against in the dfu.This is also supported by the statement in the event description, "the nurse reported not knowing - how much the floor abused it [picc] before i got to her".The customer's complaint description of slice/hole in the catheter is confirmed.A definitive root cause could not be determined from sample review; however, based on the longitudinal nature of the slice, a possible root cause could be over-pressurization.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: as noted during the review of the directions for use (dfu) that is supplied in the reported kit, the following precautions/warnings are stated: warnings: · do not use if package is opened or damaged.· do not fully insert catheter up to suture wing.· do not use sharp objects to open package as damage to the device may occur.· if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.· do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.Potential complications/adverse events catheter rupture extravasation of infusate management of lumen occlusion: provided there is no resistance with aspiration, flush the catheter vigorously with sterile normal saline to try to move the tip away from the vessel wall.Use a 10 ml or larger syringe.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis.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 TECHNOLOGY
• Common Device Name: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12605298
• Report Number: 1317056-2021-00174
• Device Sequence Number: 13787359
• Product Code: LJS
• UDI-Device Identifier: H965750335
• UDI-Public: H965750335
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 09/30/2022
• Device Catalogue Number: 75033
• Device Lot Number: 5688971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 92 KG