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

Catalog Number	1181200777T
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned sample was requested but haven't received yet.The dhr of this lot was reviewed without any issue.The design history file and 510k submission 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 no pump compatability issues with this product were received before.A recall was conducted by distributor cardinal health 200 llc with recall number z-0854-2024.The corrective 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.
Event or Problem Description
The customer reported an error message indicating "occluded" is showing on the alaris pump in the nicu department.The alaris pumps in nicu have the latest update.The occlusion alarm indicates increased back pressure sensed while infusing.The tubing has not changed.The customer states they fill the syringes before use so they are not occluded.

• 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: 19102790
• Report Number: 3005670221-2024-00076
• Device Sequence Number: 7344138
• Product Code: FMF
• UDI-Device Identifier: 10192253034691
• UDI-Public: 0110192253034691
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/14/2024

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: 1181200777T
• 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: 01/26/2024
• Initial Report FDA Received Date: 04/13/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0854-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown