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

Catalog Number	1183500777
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 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 two pump compatbility issues with this product were received before.A recall was conducted by distributor cardinal health 200 llc with recall number z-0856-2024.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.
Event or Problem Description
The customer reported that chat in nuclear radiology stated that the injection pumps were not recording the correct volume.He would setup a syringe with a 30 ml dose, but the bd alaris syringe pump would show a 32.5 volume.He was using the same setup as he always did: monoject 35 ml.He also mentioned that he got new syringes, and that the new syringes were easier to operate.After doing test with the new syringe, the initial reporter was able to confirm across every test point that the new monoject syringes were constantly about 2.4 to 2.5 ml off (extra)- they would setup a 20 ml injection, but the bd alaris showed 22.4 ml.This variance was consistent for 10,20, 30 and 35 ml.See pic for the 20 ml syringe setup- on the screen it shows'available 22.4 ml' they recalibrated the syringe pump, same results.They tried the syringe on different syringe pumps, same result, so they can rule out a bad syringe pump.Found an old syringe.Tested it.It was accurate to within a 0.2ml, which is just a drop.So they examined both syringes and found that the new monoject 35 ml syringes have a longer barrel.Since the bd alaris calibration is determined from the amount of the barrel above the zero line (the end part of the syringe body that clamps into the pump) this is causing the bd alaris to inaccurately estimate the total volume in the syringe.They are not sure if it will actually cause the reported total volume infused to be different or not.They would have to run additional test.They do not know how the bd syringe pump calculates the final volume once the pump has pressed down on the syringe to the stop point.

• 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: 19095668
• Report Number: 3005670221-2024-00017
• Device Sequence Number: 7268802
• 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): 04/12/2024

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: 1183500777
• Device Lot Number: 221201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0856-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown