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

Model Number	8881833510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
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 prior to administration of a vaccine, the plastic tip of the syringe was noticed to be bent and damaged.There was no injury to the patient or staff.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) for the reported lot number indicates that no issues were found in visual and physical samples inspected.There were no non conformance records (ncr) related to this lot.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 examined for damage and leaks.The lot met all defined acceptance requirements and was released.There was 1 sample returned for evaluation.The sample has a luer tip on the barrel that is damaged and bent on one side.The pictures attached to the complaint show the same issue with the same sample.The reported condition is confirmed.The exact root cause could not be determined based on available information.A review of the dhr, maintenance and process monitoring records showed no issues related to the reported condition.There is insufficient information to determine a most probable root cause.There was no indication of a systemic issue with the process or production.Based on available information, no corrective actions are required 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: 9732845
• Report Number: 1017768-2020-00796
• Device Sequence Number: 2352566
• 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): 04/15/2020

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 Model Number: 8881833510
• Device Catalogue Number: 8881833510
• Device Lot Number: 732141
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1