MAUDE Adverse Event Report: COVIDIEN LIFSHLD 250-E 18X1 RBLT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881202017
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: an elderly female was being treated for chronic obstructive pulmonary disease (copd) on the inpatient medical floor.When the rn was drawing up solu-medrol using a blunt needle (18 gauge, gray, monojet), a piece of the rubber stopper was able to be drawn into the syringe.The supervisor was notified.No harm to patient because it was discovered by the nurse prior to administering the medication.
Additional Manufacturer Narrative
The device history record (dhr) review could not be reviewed as no lot information provided.There were no samples returned for investigation.As no information of the reported condition could be identified within the production documentation the root cause could not be identified.As part of continuous improvements, a formal investigation has been opened to determine the root cause and implement the appropriate corrective actions to prevent the recurrence of the reported issue.This complaint will be used for qa tracking and trending purposes.

• Brand Name: LIFSHLD 250-E 18X1 RBLT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11694427
• Report Number: 1017768-2021-00926
• Device Sequence Number: 3909261
• Product Code: FMI
• UDI-Device Identifier: 10884521082892
• UDI-Public: 10884521082892
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 8881202017
• Device Catalogue Number: 8881202017
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/19/2021
• Patient Sequence Number: 1