MAUDE Adverse Event Report: CARDINAL HEALTH 20ML SYR REGULAR LUER TIP RP; SYRINGE, PISTON

Model Number	8881520673
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Customer reports: the tip is bent on the syringe.User is unsure which lot it is from.By a visual photo observation, it is apparent that the tip of the syringe is broken.

• Brand Name: 20ML SYR REGULAR LUER TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11994079
• Report Number: 1915484-2021-01256
• Device Sequence Number: 17190302
• Product Code: FMF
• UDI-Device Identifier: 20884521012179
• UDI-Public: 20884521012179
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/14/2021

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: 8881520673
• Device Catalogue Number: 8881520673
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1