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

Model Number	8881250248
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
The customer reports that when they twist off the plastic top, the needle separates from the hub and falls off.Additional information provided by the customer on 20-aug-2020 stated that when they twisted the plastic sheath off, the needle would fall off the plastic hub and onto the table.She said that they had many needles do this in one box.They opened a second box and when they tried to use the second box it would do the same thing, when they twisted the plastic sheath off, the needle would fall off the hub and onto the table.
Additional Manufacturer Narrative
The customer provided additional clarification on october 07, 2020 regarding the reported incident.The customer stated that when they twisted the plastic sheath off the cartridge, the needle/hub assembly separates from the sheath/cartridge and falls onto the table.There was no patient injury.The needle (cannula only) did not separate from the hub as originally reported but rather the needle/hub assembly detached from cartridge.Based on this clarification from the customer, this complaint is not considered reportable per mdr regulation.

• 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: 10437126
• Report Number: 1017768-2020-00840
• Device Sequence Number: 19568910
• Product Code: FMI
• UDI-Device Identifier: 20884521006222
• UDI-Public: 20884521006222
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/12/2020

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: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1