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

Catalog Number	1182000777
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported anonymously via medwatch that their hospital uses monoject syringes.The reporter stated that monoject syringes were previously manufactured by covidien.They have recently changed to cardinal health.Cardinal health is using the same reference number and monoject name, but the syringes are different.The reason this is an issue is because their hospital uses the monoject syringes on their medfusion pumps.The medfusion pumps are programmed with the parameters of the syringe.Now, when they put the monoject syringe on the medfusion pump, it cannot be recognized.They have reported this issue to cardinal health but no resolution yet.The reporter stated that they are concerned because hospitals across the country use medfusion syringe pumps and when they go to run a potentially life sustaining medication with a cardinal health monoject syringe it will not work on the syringe pumps.It seems that cardinal health should notify all of its customers of this issue.
Additional Manufacturer Narrative
The returned sample is unavailable for evaluation.The dhr of this lot was reviewed without any issue.The design history file and 510k sumbssion were reviewed.This syringe is designed for manual use only, not for pump use.For manual use or not for pump use was not presented on any labeling of this product.The compliant history was reviewed five pump compatbility issues with this product were received before.A recall was conducted by distributor cardinal health 200 llc with recall number z-0855-2024.The corretive action putting the caution "for manual use or not for pump use" on all syringes' labeling of k113091 will be taken.A follow-up report will be submitted if any additional information from the received samples.

• Brand Name: CARDINAL HEALTH
• Common Device Name: 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: 19095253
• Report Number: 3005670221-2024-00015
• Device Sequence Number: 15374101
• Product Code: FMF
• UDI-Device Identifier: 10192253034677
• UDI-Public: 0110192253034677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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
• Device Catalogue Number: 1182000777
• Device Lot Number: 221201
• 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: 09/18/2023
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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