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

Model Number	8881250248
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2020
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.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: when twisting off the plastic top, the needle separates from the hub and falls off.
Additional Manufacturer Narrative
Per additional follow-up received from the customer on 10/07/2020, this complaint is a duplicate of report number 1017768-2020-00840.Report number 1017768-2020-00839 should not have been generated and no additional reports will be submitted.

• 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: 10437146
• Report Number: 1017768-2020-00839
• Device Sequence Number: 2943066
• Product Code: FMI
• UDI-Device Identifier: 20884521006222
• UDI-Public: 20884521006222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 011144
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1