MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ WITH SMARTSLIP¿ TECHNOLOGY; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305886
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the safety cap of the bd eclipse¿ with smartslip¿ technology hypodermic syringe and needle have fallen off.The school nurse preloaded the syringe and went to slide the safety cover over, but the cover flicked off and the nurse was injured.Exposure occured, and medical intervention took place.
Additional Manufacturer Narrative
Investigation results: the affected needle is not available for our evaluation so it is not possible to do an accurate investigation of the reported issue.Review of dhr could not be performed since no lot number has been provided and after discussing the reported issue with our manufacturing technicians, it is not possible to identify root cause related to needle manufacturing process.Our assembly process has a system that inspects 100% the performance (opening and activation) of safety shield of needles, rejecting the defective ones.Based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.If samples are received in the future the complaint will be re-opened and re-investigated.

• Brand Name: BD ECLIPSE¿ WITH SMARTSLIP¿ TECHNOLOGY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7492645
• Report Number: 3002682307-2018-00109
• Device Sequence Number: 10811643
• Product Code: FMI
• UDI-Device Identifier: 00382903058860
• UDI-Public: 00382903058860
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: Nurse
• Device Catalogue Number: 305886
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention