MAUDE Adverse Event Report: CARDINAL HEALTH 12ML LUER LOCK TIP PHARM TRAY; SYRINGE, PISTON

Model Number 8881512258

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during production activities, there was one leaking/cracked syringe identified.

Manufacturer Narrative

Based on the information available to us, we were able to confirm the event, and determined that: the product was released accomplishing all quality standards according to the device history record review.One sample was received for evaluation.When reviewing the sample, it was observed that one side was cracked.When trying to push the plunger with force, the syringe leaked from the area.There were no witness marks present on the barrel where the crack was visibly seen.The sample returned contained liquid and a cap, neither of which is part of the manufacturing process.A gemba was carried out; current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger this condition therefore an exact root cause could not be determined.No corrective actions are required at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: 12ML LUER LOCK TIP PHARM TRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17759815
• MDR Text Key: 323545867
• Report Number: 9612030-2023-03827
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010970
• UDI-Public: 10884521010970
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8881512258
• Device Catalogue Number: 8881512258
• Device Lot Number: 2305712064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1