MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	H965103038181
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported: they were doing a dialysis case and as soon as they put in the sheath dilator it was dripping blood.Once they put the catheter in it was still dripping blood.As they broke it started gushing blood all over the room, all over (b)(6)'s face.The valve just did not work at all.This event meets the criteria of a reportable adverse event as there was blood (bio contaminate) sprayed on one of the nurses in attendance.No adverse effect to the attending nurse was reported.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one unopened, unused bioflo dialysis package.The device was forwarded to angiodynamics' supplier of this product for a device evaluation and root cause determination.Per the supplier: the actual complaint sample was not returned for analysis.A similar device from the same lot, unused was returned for analysis.Visual evaluation of the device from the same lot did not reveal any discrepancies.Functional evaluation to evaluate whether the valve changed the flowrate of fluid from the sheath end revealed that the sheath did not drip with the valve occluding the sheath after 15 seconds.This complaint is non-verified for the sheath mentioned in the complaint and the evaluation of the device from similar lot did not reveal any discrepancies.The complaint is unconfirmed.The reported complaint description cannot be confirmed.A root cause for the event canot be determined.A review of the device history records was performed for the reported 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 following is provided as a reference from dfu item number 16600701-01: precautions: dilators and catheters should be removed slowly from the sheath.Rapid removal may damage the valve members resulting in blood flow through the valve.Never advance or withdraw guide wire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action.Cautions: · the valved peelable introducer sheath is designed to reduce blood loss and the risk of air intake but it is not a hemostasis valve.· it is not intended to create a complete two-way seal nor is it intended for arterial use.· the valve will substantially reduce air intake.At -12 mm hg vacuum pressure the valved peelable introducer sheath may allow up to 4 cc/sec of air to pass through the valve.· the valve will substantially reduce the rate of blood flow but some blood loss through the valve may occur.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9124794
• Report Number: 1317056-2019-00122
• Device Sequence Number: 2413855
• Product Code: MSD
• UDI-Device Identifier: H965103038181
• UDI-Public: H965103038181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: H965103038181
• Device Lot Number: 5495156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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: Other