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

Catalog Number	8881101015
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
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 with any abnormal issue.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.
Event or Problem Description
It was reported anonymously via medwatch that the customer's facility uses the monoject oral syringes, 1 ml size, for oral medications needed in their nicu patients.Staff noticed that the newer version of the monoject oral syringes from cardinal health have a very loose plunger.This lack of resistance of the plunger in the barrel of the syringe allows for medication to be expelled out of the syringe despite being capped.The older/ original version of the oral monoject 1 ml syringes had more resistance with the plunger in the barrel and did not have the issue of the medication being expelled.The product number for these monoject oral syringes did not change when they were converted to the cardinal health version - product number 8881101015.No harm to any patients but pharmacy staff did have to re-draw multiple doses for patients due to expelled medication.

• Brand Name: CARDINAL
• Common Device Name: ENTERAL 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: 19465084
• Report Number: 3005670221-2024-00140
• Device Sequence Number: 19724371
• Product Code: PNR
• UDI-Device Identifier: 26971564466817
• UDI-Public: 0126971564466817
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K190502
• 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): 06/05/2024

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: 8881101015
• Device Lot Number: 230501
• 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: 04/24/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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