MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. CARDINAL; SAFE INSULIN SYRINGE

Catalog Number	8881511110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that they have seen a significant uptick in error reports with incorrect dose of insulin glargine and other subcutaneous meds that are prepared in their inpatient pharmacists and transported to the nursing unit.For example, they prepare all insulin glargine doses in pharmacy and the doses are checked by the technician drawing up the dose and the pharmacist verifying the dose before the syringe is heat-sealed.The syringe in the heat-sealed plastic bag is transported by a technician (either by hand or on a cart) to the nursing unit and placed in a plastic bin in the refrigerator.Then the nurse pulls the medication out of the refrigerator, removes it from the heat-sealed bag (they educate to cut out with scissors, but could also be pushing out), and then identifies the dose is incorrect.They have some internal opportunities that they are working to address like improving their delivery process to keep the syringes from being moved and nurses from pushing the plunger.However, due to the influx of recent events across their entire system, they are also concerned that there may be some defect with the syringe that makes it less stable for transport.They previously saw error reports roughly every 2-3 months, and now they are getting multiple reports weekly.

• Brand Name: CARDINAL
• Common Device Name: SAFE INSULIN SYRINGE
• 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: 20617643
• Report Number: 3005670221-2024-00288
• Device Sequence Number: 18005488
• Product Code: FMF
• UDI-Device Identifier: 06971564467476
• UDI-Public: 0106971564467476
• 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): 11/06/2024

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: 8881511110
• Device Lot Number: CN231001
• 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: 10/18/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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 Sex: Unknown