MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; DONOR SCREENING KIT

Model Number	DYNDB3032A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the facility that a donor had a hemoglobin finger stick and small piece of metal debris had to be removed from her finger by a physician.According to the facility, the donor had the finger stick on (b)(6) 2022.On (b)(6) 2022 the donor reached out to the facility stating she had discomfort in the finger used for the stick.She was advised to see her physician.On (b)(6) 2022 the donor saw a physician who located a small piece of debris in area of the needle stick and had it removed.According to the facility the donor states that she is, "fine and feeling much better." the sample was not returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported by the facility that a donor had a hemoglobin finger stick and small piece of metal debris had to be removed from her finger by a physician.

• Brand Name: Medline Industries, Inc.
• Common Device Name: DONOR SCREENING KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13595114
• Report Number: 1417592-2022-00019
• Device Sequence Number: 5126088
• Product Code: OEZ
• UDI-Device Identifier: 10889942172535
• UDI-Public: 10889942172535
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: DYNDB3032A
• Device Catalogue Number: DYNDB3032A
• Device Lot Number: 21LBF985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 61 KG