MAUDE Adverse Event Report: CAREFUSION, INC SU10520; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number	SU15120
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint details received: material no.: su15120 batch no.: j21xrd.Verbatim: customer was utilizing nail nipper su10520 and customers hand was cut during use of the nail nipper from a sharp point on the handle.J21xrd confirmed.What is the customer outcome? unknown at this time.(b)(6) 2022 additional information: one of our podiatry nail technicians was the one who was injured.She was squeezing down on the handle, trimming a patient¿s toenails when the pointed, sharp part on the nail clipper handle (that was sticking up) poked her in the palm of her hand.The area was cleaned, and antibiotic ointment, and band aid was applied.There was no major injury to area, just a small cut and minimal bleeding.Picture was not obtained at that time and unable to do so now since this was last week.No further information available.
Additional Manufacturer Narrative
(b)(4).On (b)(6) 2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
Additional Manufacturer Narrative
Follow up to parent complaint: (b)(4).The complaint product was returned, and an evaluation was performed.The root cause is due to a production error.The pin of the lock was not sufficiently deburred.Furthermore, in the test plan there was no corresponding test step for checking if sharp edges exist and in which position the lock must be checked.The test plan has been extended by the corresponding test step (checking for sharp edges, clarification of the position of the lock during the inspection).
Event or Problem Description
Customer was utilizing nail nipper su10520 and customers hand was cut during use of the nail nipper from a sharp point on the handle.J21xrd confirmed.What is the customer outcome? unknown at this time.12 jan 2022 additional information: one of our podiatry nail technicians was the one who was injured.She was squeezing down on the handle, trimming a patient¿s toenails when the pointed, sharp part on the nail clipper handle (that was sticking up) poked her in the palm of her hand.The area was cleaned, and antibiotic ointment, and band aid was applied.There was no major injury to area, just a small cut and minimal bleeding.Picture was not obtained at that time and unable to do so now since this was last week.No further information available.

• Brand Name: SU10520
• Common Device Name: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13239742
• Report Number: 1423507-2021-00059
• Device Sequence Number: 11744200
• Product Code: FZT
• UDI-Device Identifier: 10885403066009
• UDI-Public: (01)10885403066009
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022
• Report Date (Section F): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SU15120
• Device Catalogue Number: SU15120
• Device Lot Number: J21XRD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown