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)
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 reported that when they break the seal on the cap, the needle falls out.It does not stay seated in the hub, as it normally would.There was no patient injury.
Additional Manufacturer Narrative
Please disregard this report number (1017768-2020-00873).Additional information received after review of the device, it was determined that the needle is not detaching from the hub, instead the entire needle assembly is detaching from the sheath when the smaller end of the cartridge is twisted off.

• 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: 10575393
• Report Number: 1017768-2020-00873
• Device Sequence Number: 3735138
• Product Code: FMI
• UDI-Device Identifier: 20884521006222
• UDI-Public: 20884521006222
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/09/2020

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: 011145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1