MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 60ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1186000777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the clinician in facility found the syringe was damaged.The luer lock tip of the syringe was sheered off and a needle could not be attached.The tip was not in the packaging.There was also a chalky white substance found around the tip area.The chalky substance was on the tip of the syringe and also inside the tube.They only found one syringe in their inventory with this issue.It was found like this in the packaging when the clinician opened the packaging to use the syringe.The syringe was not used.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) was reviewed for the reported lot number showing zero issues recorded.Product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received three (3) photographs and a physical sample for product analysis.A complete visual inspection was performed to the quality inspection standard (qis).The syringe was found to have a missing syringe tip with a white chalky substance in and on the syringe.The chalky substance was found to have been introduced after the hot stamp ink barrel printing as the ink is present when the substance is wiped off.The white chalky substance appears to be thickly caked in and on the luer skirt area and on the rubber tip.Given the white chalky substance present on the syringe is confirmed to have been introduced after the hot stamp barrel printing, the root cause is determined to not be related to the barrel molding process.Additionally, review of the manufacture and online testing of the syringe assembly, it is unlikely the white chalky substance was introduced during the manufacturing process or online testing.The condition of the syringe assembly appears to be consistent with attempted use where possibly the tip broke during use causing the substance being drawn into the syringe to potentially cover the areas of the outer dimension of the syringe.The most probable root cause is determined to be a result of use by the end user.The exact cause of the broken tip could not be determined.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.However, a quality alert will be distributed to all necessary quality and production personnel to heighten awareness of the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 60ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• 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: 13789766
• Report Number: 1915484-2022-01274
• Device Sequence Number: 3906257
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• 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
• Report Date (Section B): 04/21/2022

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: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 114607X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 04/21/2022
• 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