MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY 1ML, 27 X 1/2; SYRINGE, PISTON

Model Number	11812705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle was loosely attached to the syringe.The needle unscrewed when activating the safety and caused a dirty needle stick.Additional information received from the initial reporter on 6-apr-2022 stated that the entire needle and colored hub detached from the syringe.The site was immediately washed with soap and water.Blood test completed for (b)(6).All initial results were (b)(6).Will recheck in 3 months.No further intervention done as they refused prophylactic treatment.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.No anomalies found on batch documentation.No samples were received by the customer for evaluation.Fifty pieces of retained samples were visually checked with no loosened needle or detached needle found.Five pieces of retained samples were physically tested by withdrawing and ejecting water from the syringe and finally activating the safety mechanism.No detached needles were found.Five pieces of retained samples were checked in accordance with several iso guidelines and all samples tested passed the test.Based on the available information it was not possible to define with certainty the root cause of the issue as it is not known the handling of the product by the end-user.Since no anomalies were found on connectors (based on results of tests on retained samples analysis) an exact root cause could not be determined.However, a potential root cause could be related to long-distance transportation as the vibration during long-distance transportation could make the connection between needle and syringe looser.If the end-user does not make sure the needle is attached tightly to the syringe before use, as good clinical practices state, the reported issue could occur.The packaging conformation does not allow a stricter connection (that could help to reduce the issue) because the safety arm of the needle needs to be aligned with the lugs of the plunger.There is no evidence of a trend therefore no immediate corrective action is required, and no corrective actions are planned.This complaint will be used for tracking and trending purposes and to monitor the product for reoccurrence.
Additional Manufacturer Narrative
corrected the data in h6 type of investigation from 3331, 4110, 4102 and 4112 to 3331, 4110, 11 and 4112 to reflect the accurate type of investigation completed.  .

• Brand Name: MONOJECT SAFETY 1ML, 27 X 1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14022451
• Report Number: 1282497-2022-10685
• Device Sequence Number: 19481896
• Product Code: FMF
• UDI-Device Identifier: 10884521544796
• UDI-Public: 10884521544796
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2022

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: 11812705
• Device Catalogue Number: 11812705
• Device Lot Number: 01107028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 04/05/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 06/24/2022; 06/27/2022
• 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