MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC BABYLANCE SAFETY HEELSTICK; MANUAL BLOOD LANCING DEVICE, SINGLE-USE

Model Number	BLP
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the device is returned and tested a supplemental report may be submitted.Complaints will continue to be monitored for trends.
Event or Problem Description
Reported issue: lancets had 2 blades in it instead of one.You can see on the picture where the blade is fastened to the little white tab.There was another blade sitting on top and when the nurse went to stick the baby's heel, the loose blade flew out and stuck her and the attached blade stuck the baby.Nurse was holding baby's foot to complete a heel stick.She held the baby's left leg in her left hand.She held the lancet in her right hand and when she pushed down the white piece, a sharps punctured her right pointer finger.At the same time another needle punctured the baby's left leg.After opening the lancet we found two individual needles in side.

• Brand Name: BABYLANCE SAFETY HEELSTICK
• Common Device Name: MANUAL BLOOD LANCING DEVICE, SINGLE-USE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4150 s; murray UT 84123
• Manufacturer (Section G): NINGBO MEDSUN MEDICAL CO., LTD.; no. 298 huangjipu road; ningbo, 31503 1; CH 315031
• Manufacturer Contact: thomas hirte ; 747 w 4150 s; murray, ut 84123 ; FR 84123
• MDR Report Key: 23489819
• Report Number: 1722684-2025-00015
• Device Sequence Number: 20965775
• Product Code: FMK
• UDI-Device Identifier: 00814247020123
• UDI-Public: 00814247020123
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K223900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BLP
• Device Lot Number: MSN43/2024
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown