MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MEDLINE; SYR W/NDLE,SAFETY,INSLN,

Catalog Number	SYRSI101292
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the facility that after the nurse administered insulin to a patient the nurse experienced a needle stick.Per the facility report, after injecting the insulin with her right hand the nurse attempted to use her right index finger to push the safety slide up to activate the feature and she punctured her right index finger with the used syringe.The nurse washed the area with soap and water and went to the local urgent care to have a hepatitis panel and hiv test performed per facility protocol.Per the facility report the nurse is feeling fine and there is no evidence of infection.The actual needle used was disposed of and was not returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The returned samples of this event was requested but hasn't been received till now, no sample for evaluation.The dhr of this lot was reviewed without any similar issue, the retained samples were inspected and they all meet the specification.The event can't be confirmed, the root cause can't detected currently.No action will be taken currently, this issue will be monitored.A supplemental report will be submitted if further information received.

• Brand Name: MEDLINE
• Common Device Name: SYR W/NDLE,SAFETY,INSLN,
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer (Section G): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: camel zhou ; no 23, huanxi rd zhutang town; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 19834846
• Report Number: 3005670221-2024-00204
• Device Sequence Number: 12419128
• Product Code: FMF
• UDI-Device Identifier: 10888277657298
• UDI-Public: (01)10888277657298
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K150758
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: Other
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: SYRSI101292
• Device Lot Number: 89719060002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2019
• 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 Sex: Unknown