MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3MLSFTY COMB 22X1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833215
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
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 that there are syringes that were cracked.They didn¿t notice until they were giving a rocephin injection and the medication shot out of the syringe.Additional information received from the customer stated that when a lead medical assistant (ma) was giving a patient a rocephin injection and while she was pushing the medication, she noticed the side of the syringe was cracked and the medication shot out the side.She stopped giving the injection and let the patient know what happened.There was no patient or caregiver injury or exposure.She informed the provider and he wanted the patient to get another injection.She mixed and drew up a new dose of rocephin using a new syringe and gave the patient the injection without any complications.

• Brand Name: MAGELLAN 3MLSFTY COMB 22X1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9262993
• Report Number: 1017768-2019-00717
• Device Sequence Number: 19302495
• Product Code: FMI
• UDI-Device Identifier: 10884521005792
• UDI-Public: 10884521005792
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 8881833215
• Device Catalogue Number: 8881833215
• Device Lot Number: S14396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1