MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833510
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
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 they were injecting saline from the syringe into the covid-19 vaccine vial when they noticed the saline was leaking out of the syringe and onto the nurses hand from a crack.There was no harm.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There was one opened, used sample returned for evaluation.The sample includes a 3ml syringe only.No needle was included.The sample was visually inspected and between the graduation lines, signs of cracks were observed.The sample was physically tested and the syringe leaked in the area where the crack was visually identified.The reported condition is confirmed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for leaking and damage.The exact root cause could not be determined based on available information.The sample analysis did confirm the failure, but no additional information, such as lot number, was provided to further investigate the event.A complaint history/trending review was performed on this product sku and there is no indication of a systemic issue with the product or process, so a corrective and preventative action will not be issued at this time.A quality alert was issued for awareness to the magellan area.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11552011
• Report Number: 1017768-2021-00915
• Device Sequence Number: 4204229
• Product Code: FMI
• UDI-Device Identifier: 10884521005839
• UDI-Public: 10884521005839
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/29/2021

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: 8881833510
• Device Catalogue Number: 8881833510
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1