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

Catalog Number	H965464701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the reported guidewire is a purchased device for angiodynamics, the supplier, heraeus medical has been sent notification of this event via a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, during placement of bioflo midline catheter, the guidewire became separated and required the patient to have a cut-down in ir to remove the wire.
Additional Manufacturer Narrative
A review of the device history records (dhr) 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 recent angiodynamics complaint report was reviewed for the bioflo midline product family and the failure mode "guidewire fractured." no adverse trend was identified.The guidewire from the reported event was returned in two pieces.It was forwarded along with a scar (supplier corrective action request) form to angiodynamics' supplier, (b)(4) for a dhr review of the supplier lot, root cause and corrective action (if applicable).As per the investigation conducted by (b)(4), the failure was detected on the grinded area of the wire, which is the distal section of the device.There is a 100% visual inspection of the batches manufactured.Additionally, there is a good grind profile test that has to be performed every 15 minutes along the manufacturing shift., in which it is determine that the units are within specification.Test results were reviewed on the router, tensile strength test results are all within specification.Based on those results, the unit was found within the drawing specification.(b)(4) has no corrective action specific to the returned device.(b)(4) performed a dhr review of the reported lot and found no indication of a manufacturing defect that could have impacted the reported event.Thus, the exact root cause of the guidewire fracture was unable to be determined.The directions for use for the midline catheter include instructions for guidewire hydration, placement and removal.(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: 8169468
• Report Number: 1317056-2018-00232
• Device Sequence Number: 11137462
• Product Code: FOZ
• UDI-Device Identifier: H965464701
• UDI-Public: H965464701
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K161866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: H965464701
• Device Lot Number: 5384768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention