ACUNAV *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-19 for ACUNAV * manufactured by Stryker Sustainability Solutions.

Event Text Entries

[3832111] Reprocessed catheter from stryker box states 1 of 4 on reprocessing. Image and color flow imaging not to physician standards. Physician requested processing company to be notified of catheters image quality - poor image quality on reprocessed 8fr acunav catheter. Stryker lot #1642317. Reuse cycle 1 out of 4. Catheter removed from use and new catheter opened. Stryker rep is aware of product issue. No harm patient harm occurred. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3299611
• MDR Report Key: 3299611
• Date Received: 2013-07-19
• Date of Report: 2013-07-19
• Date of Event: 2013-06-04
• Report Date: 2013-07-19
• Date Reported to FDA: 2013-07-19
• Date Reported to Mfgr: 2013-08-21
• Date Added to Maude: 2013-08-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACUNAV
• Generic Name: ULTRASOUND CATHETER
• Product Code: OWQ
• Date Received: 2013-07-19
• Model Number: *
• Catalog Number: *
• Lot Number: 1642317
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER SUSTAINABILITY SOLUTIONS
• Manufacturer Address: 5300 REGIONS COURT LAKELAND FL 33815 US 33815

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-19