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

Catalog Number	SSN101272F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, there were 2 incidences of a needle stick after administering heparin'.The customer reported the needle was found to be poking out of the small square opening on the safety shield'.According to the customer, both patients the needle was used on were negative for hiv, hepatitis b and c, so no prophylaxis was recommended or taken'.The customer reported no medical intervention or serious injury occurred related to this event.Sample requested to be returned.No additional information is available at this time.There was no serious injury identified, follow up care needed or medical intervention reported related to the incident.
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 currrently.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
• 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: 19834849
• Report Number: 3005670221-2024-00217
• Device Sequence Number: 6628209
• Product Code: FMF
• UDI-Device Identifier: 10193489037838
• UDI-Public: (01)10193489037838
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K193526
• 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 Catalogue Number: SSN101272F
• Device Lot Number: 89722050001
• 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: 05/01/2022
• 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