MAUDE Adverse Event Report: NULL JELCO LANCETS NEOHEEL; HEEL INCISION SAFETY LANCET

Catalog Number 1052N

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 10/15/2021

Event Type  Injury  

Event Description

It was reported that during blood sampling for blood glucose tests, the lancet cut the baby's heel and the blood still leaked out 3 hours.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-03212.The report was submitted in error.

• Brand Name: JELCO LANCETS NEOHEEL
• Type of Device: HEEL INCISION SAFETY LANCET
• Manufacturer (Section G): NULL
• MDR Report Key: 13514580
• MDR Text Key: 285467761
• Report Number: 3012307300-2022-03212
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K210745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1052N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention