MAUDE Adverse Event Report: CARDINAL HEALTH 3ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	1180100555
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: qc has sampled 80 syringes and found one with deformed / slightly broken end and two with small threads of plastic.
Additional Manufacturer Narrative
A device history record (dhr) for all reported lot¿s did not indicate any exception that could lead to the reported incident.A product analysis was unable to be completed as to date no samples have been provided.A photograph was submitted with this complaint however the reported condition could not be confirmed solely on the photograph as the product could not be identified in the photo.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue; therefore, the root cause is undetermined.If additional information or evidence becomes available, the complaint will be reopened and the root cause reassessed.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 3ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11942805
• Report Number: 1017768-2021-00948
• Device Sequence Number: 4423964
• Product Code: FMF
• UDI-Device Identifier: 20884521012858
• UDI-Public: 20884521012858
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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
• Operator of Device: No Information
• Device Model Number: 1180100555
• Device Catalogue Number: 1180100555
• Device Lot Number: 022362
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1