MAUDE Adverse Event Report: COVIDIEN 60ML LUER LOCK PHARMACY TRAY; SYRINGE, PISTON

Model Number 8881560232

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

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 Description

Customer reports: the syringe tips are breaking off.

Manufacturer Narrative

Please disregard this report number (1915484-2021-01242) as this report was inadvertently filed as a malfunction however based on clarification for this specific oem (outside equipment manufacturer) and product id, cardinal health is not considered to be the manufacturer subject to the reporting requirements of the mdr regulation as this oem repackages or otherwise changes the container, wrapper, or labeling of this device in furtherance of the distribution of the device from the original place of manufacture.

• Brand Name: 60ML LUER LOCK PHARMACY TRAY
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11753138
• MDR Text Key: 249061709
• Report Number: 1915484-2021-01242
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00884521012271
• UDI-Public: 0884521012271
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881560232
• Device Catalogue Number: 8881560232
• Device Lot Number: 2011313064
• Date Manufacturer Received: 04/28/2021
• Patient Sequence Number: 1