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

Model Number	8881833510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
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 giving the injection, the vaccine shot out of the back of the syringe past the plunger.The child needed another poke to receive the vaccine.Additional information received on 14-may-2019 stated that the child was to get tetanus-diptheria-pertussis-polio- hib vaccine in that syringe.Furthermore it was stated that the child did not receive any vaccine from the initial syringe as the medical all came out the plunger end of the syringe.
Additional Manufacturer Narrative
There was no lot number provided with this complaint, therefore it was not possible to complete a review of the lot history.One sample was received for evaluation and an inspection of the sample resulted in confirmation of the reported leaking condition.The samples were visually inspected, specifically in the luer of the hub of the needle.An observation of the sample concluded that the product was malformed into an oval-like shape at the luer lock tip resulting in circularity issues.The sample was physically tested per product specification for leakage.The sample leaked from both the luer lock tip and fluid blow by behind the plunger tip.This complaint will be considered confirmed.The exact root cause of the reported condition could not be determined without a review of the lot history.Since a root cause could not be identified, no corrective or preventive action is planned at this time.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: 8609956
• Report Number: 1017768-2019-00640
• Device Sequence Number: 11262538
• Product Code: FMI
• UDI-Device Identifier: 10884521005839
• UDI-Public: 10884521005839
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/12/2019

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: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1