MAUDE Adverse Event Report: COVIDIEN MAGELLAN TB 1 ML 27X1/2; SYRINGE, PISTON

Model Number	8881882712
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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 even though there was an audible ¿click¿ the protecting element has not covered the full needle.The sharp tip of the needle was protruding, and the personnel member got pricked.
Additional Manufacturer Narrative
Updated to reflect adverse event.Updated to reflect other serious (important medical events).Updated to include additional information provided by the customer on (b)(6) 2019.Updated to reflect serious injury.
Event or Problem Description
On (b)(6) 2019 additional information was received stating that the needle had been used prior to the needle stick therefore the needle was contaminated.The personnel is doing well and will be monitored through serologic studies.

• Brand Name: MAGELLAN TB 1 ML 27X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9439221
• Report Number: 1915484-2019-01107
• Device Sequence Number: 2499813
• Product Code: FMF
• UDI-Device Identifier: 20884521005911
• UDI-Public: 20884521005911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881882712
• Device Catalogue Number: 8881882712
• Device Lot Number: 921047X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other