MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SAFE-T-LANCE PLUS; LANCET

Model Number 1014

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Material Separation (1562); Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/13/2015

Event Type  malfunction  

Event Description

Nursing brought it to our attention in materials that the safe-t-lance devices are coming apart in the box.We pulled a new box off of the shelf, cut the seal and found 3 lancets with the button cover missing, the spring falling out of the device out and one needle tip exposed.I'm told that several nurses have received finger sticks from the button side of the device.Initially the sales rep said she hadn't heard anything about the lancets coming apart.When she called me back, she stated quality was aware of other hospitals having the reported problem.The rep suggested we convert to another size needle that hasn't had any reports of failure for now and to return for credit all of our remaining product.Manufacturer response for finger lancet, safe-t-lance plus (per site reporter): initially the sales rep said she hadn't heard anything about the lancets coming apart.When she called me back, she stated quality was aware of other hospitals having the reported problem.The rep suggested we convert to another size needle that hasn't had any reports of failure for now and to return for credit all of our remaining product.

• Brand Name: SAFE-T-LANCE PLUS
• Type of Device: LANCET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 5161282
• MDR Text Key: 28695660
• Report Number: 5161282
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2020
• Device Model Number: 1014
• Device Catalogue Number: 1014
• Device Lot Number: V44K436C9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other