MAUDE Adverse Event Report: COVIDIEN 1/2CC E100 SAF 29X1/2; SYRINGE, PISTON

Model Number	8881511136
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/25/2021
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.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 the slide safety feature on the insulin syringe does not stay in place.It can be easily retracted and caused a needle stick during activation.
Additional Manufacturer Narrative
Without a known lot number, the device history record (dhr) cannot be reviewed.The manufacturing facility has not received any samples or photos for evaluation.Therefore, the reported issue could not be confirmed.Based on an e-mail communication, the customer was unaware of the locking feature of the safety shield as described in the ifus.To permanently lock the syringe, the shield should be extended forward until it clicks, then twisted in either direction until it clicks again to indicate the final-lock.No trend of confirmed failures was observed for this reported condition, for this item code for the review period.The criteria are not met for a formal investigation, at this time.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.This complaint will be used for tracking and trending purposes.

• Brand Name: 1/2CC E100 SAF 29X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11711055
• Report Number: 1915484-2021-01238
• Device Sequence Number: 3999123
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: Health Professional
• Device Model Number: 8881511136
• Device Catalogue Number: 8881511136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other