MAUDE Adverse Event Report: COVIDIEN HYPO NEEDLE 25G X 1 A BEV RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881250305
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported after attaching the needle to the syringe the needle disconnects from the syringe.There was no patient harm.
Additional Manufacturer Narrative
The device history record review concluded that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records were reviewed for the reported lot and no related event occurred during the overall process for this lot.Also, each lot is released based on an acceptable quality limit (aql) inspection.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.The manufacturing site has not received any samples with this customer report.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: HYPO NEEDLE 25G X 1 A BEV RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11287821
• Report Number: 1017768-2021-00903
• Device Sequence Number: 3543505
• Product Code: FMI
• UDI-Device Identifier: 20884521013817
• UDI-Public: 20884521013817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: 8881250305
• Device Catalogue Number: 8881250305
• Device Lot Number: 908411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1