MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO MIDLINE; MIDLINE CATHETER

Model Number	46012
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
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
An angiodynamics territory manager reported an issue with a bioflo midline 4f catheter.One day after placement, the midline would not flush.After several troubleshooting attempts, the line was removed.The catheter could not be flushed, even after removal.The patient did not experience any adverse effects or harm as a result of this incident and had another bioflo fr catheter inserted.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one single lumen bioflo midline catheter.As received, the catheter appeared used.The catheter was contaminated with clear fluid inside and out.The sl bioflo midline catheter was trimmed at the 20cm mark.Functional testing was performed on the returned device.The device was able to be flushed with no issues.Device functioned as intended.The customer's reported complaint description cannot be confirmed.There was no damage or device non-conformance observed during evaluation of the returned sample.A root cause for the reported event cannot be determined.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.Labeling review: the dfu that is supplied in the reported kit contains the following precaution and warnings: warning contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping.Management of lumen occlusion the lumens of bioflo midlines may infrequently become obstructed.Lumen obstruction is usually evident by failure to aspirate or infuse through the lumen or inadequate flow and/or high resistance pressures during aspiration and/ or infusion.The causes may include but not limited to catheter tip malposition, catheter kink, or clot.One of the following may resolve the obstruction: verify there is no kinked tubing in the catheter section external to the body.Reposition the patient.Have the patient cough.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 any 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.Complaint reference (b)(4).

• Brand Name: BIOFLO MIDLINE
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• MDR Report Key: 10359633
• Report Number: 1317056-2020-00128
• Device Sequence Number: 11628839
• Product Code: FOZ
• UDI-Device Identifier: H965460120
• UDI-Public: H965460120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2020

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 Expiration Date: 05/31/2023
• Device Model Number: 46012
• Device Catalogue Number: 46012
• Device Lot Number: 5580554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86