MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO WITH PASV; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965458320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device from the reported event is expected to be returned to (b)(4), it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.Device not yet returned to manufacturer.
Event or Problem Description
As reported by (b)(4)' distributor in the (b)(4): "double lumen picc placed for parenteral nutrition on (b)(6) 2016.Purple lumen dedicated for administration of parenteral nutrition with icu medical tpn bung.White lumen used for intravenous antibiotic and fluids with bionector needle free connector.On attempting to replace the bionector on the white lumen the purple hub section was reported to shatter and break off leaving a small segment and the catheter open ended.The catheter was immediately removed and required replacement." no patient injury was reported.The used device is expected to be returned for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The (b)(6) 2016 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "hub broken/cracked {pasv & hybrid}." no adverse trend was identified.As received, the catheter was trimmed at the 45cm mark.The white/purple valve was broken near the point of insertion into the oversleeve.It was not returned, however the barbed end remained inside the oversleeve of the returned catheter.No manufacturing non-conformances or out of specification conditions were observed during sample evaluation.Although no definitive root cause could be determined from the sample review, the he defect appears to have been caused by exertion of excessive force on the valve component, i.E., handling damage by the end user.Angiodynamics manufacturing process controls on the picc device include 100% inspection of each valve for damage or defects.Damage to the valve, if present would likely have been identified during this inspection.The directions for use that is supplied with the reported device 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." (b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO WITH PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5587107
• Report Number: 1317056-2016-00054
• Device Sequence Number: 255781
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2016

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: 06/30/2017
• Device Catalogue Number: H965458320
• Device Lot Number: 4897631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1