MAUDE Adverse Event Report: COVIDIEN MAGELL INSULIN 1/2ML 29GX1/2; SYRINGE, PISTON

Model Number 8881892950

Device Problem Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/27/2020

Event Type  Injury  

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 Description

The customer reported that after administering the insulin, when activating the safety on insulin syringe it jammed and the tip of the needle pricked the users palm.

• Brand Name: MAGELL INSULIN 1/2ML 29GX1/2
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9717358
• MDR Text Key: 179709274
• Report Number: 1915484-2020-01128
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521005945
• UDI-Public: 10884521005945
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2020

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
• Device Operator: No Information
• Device Model Number: 8881892950
• Device Catalogue Number: 8881892950
• Device Lot Number: 925972X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other