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

Model Number	8881833510
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
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 the staff was demonstrating with the syringes and found a needle with the safety shield already deployed in the package.This issue was discovered prior to use.There was no patient/staff injury.
Additional Manufacturer Narrative
The device history record was reviewed for the reported lot # 821918 and indicated that the product was released accomplishing all quality standards.Representative samples have been received with this complaint record with lot numbers 820834, 826105 and 820833.The device history record for the lot numbers 820834, 826105 and 820833 was reviewed, and indicated that the product was released accomplishing all quality standards.Five (5) samples (1 sample from lot number 820834, 2 samples from lot number 820833, and 2 samples from lot number 826105) were returned to the manufacturing plant as a representative sample.All 5 samples had the safety shield in the correct position as they are packaged.The reported condition of a safety shield issue could not be confirmed.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product.The process monitoring data was reviewed for the assembly equipment and there were no issues related to the reported condition.A review of the machine setup was conducted and there were no issues.A review of the manufacturing equipment was performed as part of this investigation.The review found no issues with the equipment or process related to the reported condition.A specific root cause could not be determined as the reported condition was not confirmed and there were no related issues found in a review of manufacturing records.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.

• 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: 9440182
• Report Number: 1017768-2019-00748
• Device Sequence Number: 3542336
• 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): 03/10/2020

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: 821918
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1