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

Model Number	8881882712
Medical Device Problem Codes	Human-Device Interface Problem (2949); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
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
The customer reported that the safety device that must be pushed up the needle after administration was blocked, remaining stuck at the bottom, unable to secure the needle.When the staff wanted to re-cap the needle (which is contraindicated, she was told and well aware of this) but the needle pierced the cap and she pricked herself.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.Section h6 (health effect - impact code) has been added.
Event or Problem Description
The customer reported that the safety device that must be pushed up the needle after administration was blocked, remaining stuck at the bottom, unable to secure the needle.When the staff wanted to re-cap the needle (which is contraindicated, she was told and well aware of this) but the needle pierced the cap and she pricked herself.Additional information was received from the customer and it was stated that the needle was put inside the cap and then the needle pierced through the cap.After use, the safety shield was slide to the top during shield activation, but remaining stuck at the bottom, unable to secure the needle.Prior to activating the shield and during activation, needle bend was not observed.The customer further stated that as a medical intervention, the staff was given subcutaneous injection of calciparine.Serology test was performed for both the patient and the nurse and the test results were negative.There was no follow-up testing or medical treatment required.The current status of the staff is not declared.

• 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: 11248051
• Report Number: 1915484-2021-01204
• Device Sequence Number: 3977403
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other