MAUDE Adverse Event Report: CARDINAL HEALTH 1CC MAGELLAN TB 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881811558
Medical Device Problem Codes	Break (1069); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the staff reviews of the safety needles have not been favorable.They stated that the safety shield is not user friendly and gets caught and both the needle and safety shield are very flimsy and bend extremely easily.When they push the covering over the needle using the thumb, finger, and flat surface techniques, they think it¿s covered but they have to push harder to get it to snap securely.The safety mechanism has bent exposing a broken needle and the needles have bent when administering an intermuscular shot in the deltoid, when putting on the safety, and when administering and drawing up product.When giving multiple shots on a child, they need a safety feature that works quickly and effectively every time.They have had several needle sticks due to the safety not fully engaging and don¿t want to put their patient¿s safety at harm.The exact number of clinicians that have experienced needle sticks and the details of each event are unknown but per the customer the treatment protocol for bbpi was followed including blood work, follow up blood work, possible pep (post-exposure prophylaxis) and updating tetanus.The specifics of treatment for each incident could not be provided.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.There were no photos of physical samples received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 1CC MAGELLAN TB 25X5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 16792094
• Report Number: 1915484-2023-01313
• Device Sequence Number: 5522636
• Product Code: FMI
• UDI-Device Identifier: 10192253025378
• UDI-Public: 10192253025378
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8881811558
• Device Catalogue Number: 8881811558
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/17/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown