MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; MIDLINE CATHETER

Model Number	H965464801
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device used in the reported event is expected to be returned to angiodynamics, but has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not yet returned to manufacturer.
Event or Problem Description
As reported, an indwelling bioflo midline catheter had to be removed and replaced because the "hub broke." it was indicated that "it may have been cut by the patient." no patient injury was reported.It has been indicated that the used device will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and picc assembly 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 january 2017 angiodynamics complaint report was reviewed for the bioflo midline catheter product family and the failure mode "hub broke." no adverse trend was identified.The end user's report of a broken hub is confirmed, as the hub of the catheter on the returned device was broken near the point of insertion into the oversleeve.The hub, itself, was not returned.No manufacturing non-conformances or out-of-specification conditions were observed during the sample evaluation.Although an exact root cause for the damage is unable to be determined, it appears that excessive force was exerted on the valve component resulting in breakage.Angiodynamics' manufacturing process controls for the bioflo midline catheter include visual inspection for molding damage or defects.The directions for use that is supplied in the reported kit contains the following precaution/warning: "it is recommended that only luer lock accessories be used with the bioflo midline catheter with endexo technology.Repeated over-tightening may reduce hub connector life.Do not use hemostats to secure or remove devices with luer lock hub connections." (b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5864497
• Report Number: 1317056-2016-00121
• Device Sequence Number: 879281
• Product Code: FOZ
• UDI-Device Identifier: H965464801
• UDI-Public: H965464801
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K150407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: 04/30/2018
• Device Model Number: H965464801
• Device Lot Number: 5030273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1