MAUDE Adverse Event Report: BAYER LANCET

Device Problems Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/19/2015

Event Type  Other  

Event Description

Item: bayer contour next ez lancet device and lancets.The above pt had used the lancet device and the needle was still in the device.The cap has to be pulled off to remove the lancet, unlike other devices, such as the one touch delica which easily and smoothly twists off.I was familiarizing myself with the pt's lancet device and as i pulled the cap off it gave way with a jerk which caused the needle to embed in the ring finger of my left hand near the cuticle (i am right handed).The wound subsequently bled, creating a contaminated needle stick injury.I tried several other times to remove the cap and found each time it gave way with a jerk.This may be appropriate for some types of caps, but not when there is a sharp needle exposed just underneath it.The pt then demonstrated removal technique for the lancet: she stated the instructions said to push the needle into the round disk that came on the end of the lancet.In doing this maneuver it was noted the disk did not stay on the needle.Ultimately the pt had to use a dinner knife to wedge the needle out of the device in order to get it out at all, much less without getting stuck inadvertently.The one touch delica lancets have an actual cap that goes over the needle as opposed to a disk and it is designed such that the user can then grab the cap and pull the needle out of the machine by it and it stays on, as demonstrated by this pt.The pt was required by her insurance carrier, (b)(6), to change machines, test strips and lancets and this was the device her pharmacy, (b)(6), sent over on a script request as the preferred device.This is a far inferior product, poorly designed, and no doubt will create many other needle stick injuries, especially among pts who are used to the smooth and safe operation of other products.This pt also points out many diabetics already have neuropathy which makes it difficult to get the cap off at all and increases the likelihood of needlestick injuries.

• Brand Name: LANCET
• Type of Device: LANCET
• Manufacturer (Section D): BAYER
• MDR Report Key: 4545866
• MDR Text Key: 5524003
• Report Number: MW5040891
• Device Sequence Number: 2
• Product Code: FMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 118