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

Model Number	8881250248
Medical Device Problem Codes	Fitting Problem (2183); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
Date of Event	09/24/2020
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 reported that when they opened the box, many of the needles don't attach to syringe in a way that, the cap can stay on.It¿s like the needle threads are too deep for the cap to be re-applied.The customer further stated that this isn't good, as they carry euthanasia solution to a pet or vaccines, etc.There was no patient injury reported.
Additional Manufacturer Narrative
Please disregard this report number (1017768-2020-00874).Further information provided by the customer stated the issue is with the needle assembly not sitting correctly in the sheath.When they remove the short end of the cartridge and screw the covered needle onto the syringe, many times the needle cover will no longer lock onto the needle and it falls off.
Event or Problem Description
The customer reported that when they opened the box, many of the needles don't attach to syringe in a way that, the cap can stay on.It¿s like the needle threads are too deep for the cap to be re-applied.The customer further stated that this isn't good, as they carry euthanasia solution to a pet or vaccines, etc.There was no patient injury reported.Additional information was provided by the customer and it was stated that when they try to attach the needle onto the syringe, the plastic hub of the needle is not properly attaching to the syringe.The hub of the needle is not long enough to attach onto the syringe.The customer further stated that if they give extra pressure and twist the needle onto the syringe, the cap won¿t stay on and the technician have stuck themselves with the clean needle.There was no medical intervention or treatment required.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.Section b6 patient code has been updated to include the clean needle stick injury.Section b6 device code has been corrected, based on the additional information provided by the customer.

• 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: 10610170
• Report Number: 1017768-2020-00874
• Device Sequence Number: 3885837
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 09/29/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/07/2020; 10/09/2020
• Patient Sequence Number: 1