MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833310
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2020
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 the nurse was drawing up medication into the syringe and noticed that the side of the syringe was cracked and the medication was leaking out.
Additional Manufacturer Narrative
Corrected the reported lot number from 680 to 000680 in section d4.
Additional Manufacturer Narrative
Section g4 was updated from 08-may-2020 to 12-may-2020.The initial reporter reported this event on (b)(6) 2020.

• Brand Name: MAGELLAN 3ML SFTY COMBO 23X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 10067985
• Report Number: 1017768-2020-00827
• Device Sequence Number: 776906
• Product Code: FMI
• UDI-Device Identifier: 10884521005815
• UDI-Public: 10884521005815
• 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,Followup
• Report Date (Section B): 05/28/2020

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 Expiration Date: 11/30/2024
• Device Model Number: 8881833310
• Device Catalogue Number: 8881833310
• Device Lot Number: 000680
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 05/12/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 05/19/2020; 05/28/2020
• Patient Sequence Number: 1