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

Catalog Number	1188100777
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned samples and lot number of this event was requested but hasn't been received till now, no sample for evaluation and no dhr for review.The issue 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.
Event or Problem Description
Customer feedback: after insulin is drawn up in this syringe, recapping the syringe pushes 1-2 units of air into the syringe causing it to appear as though the dose is larger than it actually.

• Brand Name: CARDINAL
• Common Device Name: 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: 20142292
• Report Number: 3005670221-2024-00265
• Device Sequence Number: 11538529
• Product Code: FMF
• UDI-Device Identifier: 10192253034783
• UDI-Public: 0110192253034783
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K151949
• 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): 09/05/2024

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: 1188100777
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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