MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number	1183500777
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: the pharmacy team has been seeing issues on their icu med spiros product leaking when using with the monoject syringes.In reviewing the products and failed devices, the clinical team noticed that the luer lock tip on the monoject syringes has shortened and the packaging has changed from what they are used to seeing.

• Brand Name: 35ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11913019
• Report Number: 1915484-2021-01254
• Device Sequence Number: 11872106
• Product Code: FMF
• UDI-Device Identifier: 10884521010826
• UDI-Public: 10884521010826
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 1183500777
• Device Catalogue Number: 1183500777
• Device Lot Number: 032827X
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1