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

Model Number 8881511136

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

The customer reported that the extra twist in the syringe is not working.There was no harm reported.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Section b5 has been updated to include additional information.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 303895256
• Report Number: 1915484-2022-01282
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 06/23/2022; 06/23/2022
• Supplement Dates FDA Received: 07/19/2022; 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1