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

Catalog Number	435SE
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
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 one pump compatbility issues with this product was received before.A recall was conducted by distributor cardinal health 200 llc with recall number z-0849-2024.The corrective action putting the caution "for manual use or not for pump use" on all enteral syringes' labeling of k190502 will be taken.A follow-up report will be submitted if any additional information from the received samples.
Event or Problem Description
As always been this code whether the packaging said covidien or cardinal.Additional information provided by (b)(6) on 31oct2023 stated that she manages the software for the pumps in the nicu (in which the syringes in question are incompatible with).They use the medfusion 4000 pumps (version v1.6.1) managed by icu medical (formerly smiths medical).She reached out to the pump vendor to inquire about more information.The rep she spoke with indicated that this enfit syringe issue is related to a similar problem with luer-lock syringes reported over the last couple of months.Currently, they still have supply in the nicu of the monoject enfit syringes (ref (b)(4)), but it's the old covidien packaging, lot 322648x.The incompatible lot number is 230501 with the cardinal health monoject packaging.They are asking whether that above lot number (230501) is unique and the only incompatibility issue they will encounter, or have there been issues reported with the cardinal health branded monoject enfit syringes (similar to the luer-lock syringe issues)? they have some other options to manage this issue with the pumps, but was wondering if there was any further information.

• Brand Name: CARDINAL HEALTH
• Common Device Name: ORAL 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: 19095875
• Report Number: 3005670221-2024-00018
• Device Sequence Number: 7408471
• Product Code: PNR
• UDI-Device Identifier: 06971564466240
• UDI-Public: 0106971564466240
• 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
• 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: 435SE
• 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: 11/07/2023
• Initial Report FDA Received Date: 04/12/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0849-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown