MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER; FIE

Model Number	820700533
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The donor donated on (b)(6) 2024, with no complications noted while he was in the plasma center.On (b)(6) 2024, the donor experienced arm discomfort around the venipuncture (vp) site, initially attributing it to a workout.Despite the donor's use of ice and heat, the discomfort did not resolve.The donor visited the er on (b)(6) 2024, where he reported that an x-ray of the left forearm revealed that part of the needle was beneath the vp site.The mss (physician substitute) advised the donor to provide medical records and a biolife mss would follow up.Currently, the donor has not provided any additional information or medical records.Importer is in communication with facility and trying to get the needle back to manufacturer after it is extracted from patient to ensure this is jms needle.At this point there has been no update from patient.
Additional Manufacturer Narrative
Currently, the importer is working with the facility to return the extracted metal for verification.We cannot confirm if it is jms needle.Based on the results of the preserved samples evaluation and dhr there was no abnormality found on the reported complaint lot.Our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.Refer to attached report cir/056/avf/24.

• Brand Name: WINGEATER
• Common Device Name: FIE
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440; ang mo kio industrial park 1; singapore 56962 0; SN 569620
• Manufacturer (Section G): JMS SINGAPORE PTE LTD; 440; ang mo kio industrial park 1; singappore, 56962 0; SN 569620
• Manufacturer Contact: chin yin chia ; 440; ang mo kio industrial park 1; singapore, 56962-0 ; SN 569620
• MDR Report Key: 20263857
• Report Number: 3002807350-2024-00001
• Device Sequence Number: 8723273
• Product Code: FIE
• UDI-Device Identifier: 08888483005390
• UDI-Public: 08888483005390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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: Other
• Device Model Number: 820700533
• Device Catalogue Number: 820700533
• Device Lot Number: 230614391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 32 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White