MAUDE Adverse Event Report: HTL-STREFA S.A. NIPRO SP 28G; LANCET - FMK

Model Number 610

Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Bruise/Contusion (1754); Pain (1994); Skin Irritation (2076)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

A needle remained in the finger following puncture.The needle was removed with tweezers.

• Brand Name: NIPRO SP 28G
• Type of Device: LANCET - FMK
• Manufacturer (Section D): HTL-STREFA S.A.; 7 adamowek street; ozorkow 95-0 35; PL 95-035
• Manufacturer (Section G): ALEKSANDRA PRAZMOWSKA-WILANOWSKA; htl-strefa s.a.; 7 adamowek street, 95-035; ozorkow ; PL
• Manufacturer Contact: jarek moleda, us agent ; 3005 chastain meadows pkwy, ste 300; marietta, GA 30066 ; 7236598
• MDR Report Key: 4865097
• MDR Text Key: 22240607
• Report Number: 9613304-2015-00001
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: 610
• Device Catalogue Number: 7258
• Device Lot Number: U11K84B2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1