MAUDE Adverse Event Report: COVIDIEN 250E NDL 22 X 3/4 A; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881250248
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's email address should reflect: (b)(6) due to character limit restrictions the entire email address could not fit in this field.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
The customer reported that the caps were loose and the needles were leaking around the hub.There were no injuries reported.
Additional Manufacturer Narrative
A device history record of the reported lot was not performed during this investigation as the lot number ¿23067¿, provided with the complaint is not a valid lot number for any product manufactured at the cardinal facility.All device history records are reviewed and approved by quality prior to release of product.The sample was not provided for evaluation therefore the reported condition could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 250E NDL 22 X 3/4 A
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11011881
• Report Number: 1017768-2020-00890
• Device Sequence Number: 3814032
• Product Code: FMI
• UDI-Device Identifier: 20884521006222
• UDI-Public: 20884521006222
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 8881250248
• Device Catalogue Number: 8881250248
• Device Lot Number: 23067
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/29/2021
• Patient Sequence Number: 1