MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT SFTY INS NDL 29X1/2IN 0.5ML; SYRINGE, PISTON

Model Number	8881511136
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the extra twist in the syringe is not working.There was no harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Event or Problem Description
The customer reported that the extra twist in the syringe is not working.There was no harm reported.Additional information was received and stated that the safety shield extended forward during activation and the issue was noticed during permanently engaging the safety shield of the syringe.Per customer, there was an audible click heard during the twist.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was packaged on 09feb2022.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.If a sample is returned in future, this file will be re-opened for further investigation.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT SFTY INS NDL 29X1/2IN 0.5ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14933266
• Report Number: 1915484-2022-01282
• Device Sequence Number: 5145738
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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 Model Number: 8881511136
• Device Catalogue Number: 8881511136
• Device Lot Number: 205243X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 06/23/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/19/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown