* NL-1901

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-05-27 for * NL-1901 manufactured by V. Mueller.

Event Text Entries

[141799] Pt admitted for lap-assisted vaginal hysterectomy. A yankauer suction tip was attached to catheter. During case, catheter was dropped on the floor, where it remained until end of procedure. After procedure, it was noticed that the tip was missing from the dropped catheter. An x-ray was ordered on the recovering pt and the tip was found in the pt's abdomen. Pt was taken back to operating room for laparoscopic removal of tip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 233600
• MDR Report Key: 233600
• Date Received: 1999-05-27
• Date of Report: 1999-04-23
• Date of Event: 1999-02-25
• Date Facility Aware: 1999-02-25
• Report Date: 1999-04-23
• Date Reported to Mfgr: 1999-04-23
• Date Added to Maude: 1999-07-30
• 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: 0
• 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: *
• Generic Name: YANKAUER SUCTION TIP
• Product Code: KCB
• Date Received: 1999-05-27
• Model Number: NL-1901
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 226425
• Manufacturer: V. MUELLER
• Manufacturer Address: 1435 LAKE COOK RD. DEERFIELD IL 60015 US
• Baseline Brand Name: YANKAUER SUCTION TUBE W/SCREW TIP
• Baseline Generic Name: INSTRUMENT
• Baseline Model No: AS165
• Baseline Catalog No: AS165
• Baseline ID: NA
• Baseline Device Family: INSTRUMENT
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-05-27