MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 23 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850310

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The customer reported that medication was leaking from the magellan safety needle during an injection.There is no known patient impact.

Manufacturer Narrative

H 3 evaluation summary.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.There was 1 opened sample returned for evaluation.The sample was visually inspected, and no visual issues were found.The returned sample was tested for leakage and the reported condition could not be confirmed.The lot number was confirmed by the needle package returned with the sample.The root cause analysis did not identify any issues with the manufacturing process for the needles that would have caused this issue.There¿s no indication of a systemic issue with the product or process, so a corrective and preventative action (capa) will not be issued at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: SAFETY NEEDLE 23 X 1
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9506954
• MDR Text Key: 173083587
• Report Number: 1017768-2019-00763
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10884521000544
• UDI-Public: 10884521000544
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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
• Device Operator: No Information
• Device Model Number: 8881850310
• Device Catalogue Number: 8881850310
• Device Lot Number: 901108
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 02/14/2020
• Patient Sequence Number: 1