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

Catalog Number	1188100777
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this item has caused two near misses because of the elongated plunger on the syringe and has become a safety issue for clinicians administering the dosage, due the change made on the conical plunger in november.The customer reported that the item has caused a near miss because of the elongated plunger on the syringe and stated it has become a safety issue for clinicians administering the dosage, due the change made on the conical plunger in november.Additional information received on 27mar2024 stated that in the acute care unit a nurse drew up ordered 10 units insulin in the monoject 1 ml insulin syringe with luer-lock with tip cap (u-100).Lot #221201.Per their safety practice, she went to obtain dual verification of the dose drawn up from a second nurse.The second nurse was confused by the new design and was not certain where to measure the dose (base of plunger or conical tip of plunger).The second nurse advised discarding and drawing up dose in a sq syringe where it was clear to use the base of plunger as dose marker.The dose was drawn up using conical tip of plunger -if given, that would have been 27 units of insulin.
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 without any similar issue, the retained samples were inspected and they all meet the specification.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.

• Brand Name: CARDINAL
• Common Device Name: INSULIN 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: 19786273
• Report Number: 3005670221-2024-00197
• Device Sequence Number: 15470990
• Product Code: FMF
• UDI-Device Identifier: 10192253034783
• UDI-Public: 0110192253034783
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K151949
• 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): 07/20/2024

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: 1188100777
• 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: 03/19/2024
• Initial Report FDA Received Date: 07/20/2024
• 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