MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ NEEDLE; SAFETY ENGINEERED SAMPLE NEEDLE

Catalog Number	305894
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Results: photo investigation: a photo was returned for investigation, the picture of affected sample show a used needle with no activated safety shield: cannula is not totally cover by the safety shield.The customer complaint about safety shield failure; samples pictures show no defect.Dhr/bhr review: our production and inspection records for batch 1608002 have established that all production and quality processes were carried out normally.No ncmr's.Unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode.Capa determination results: no - based on an evaluation of severity and occurrence and since complaint is not confirmed because no defect was identified, it was determined that no corrective action is required at this time.
Event or Problem Description
It was reported that while a nurse was taking a blood sample, the safety cover on a bd eclipse¿ needle failed to activate causing a needle stick to the nurse¿s right forefinger.Antivirals were prescribed but could not be taken due to contraindications with other medications.Comparative blood samples are scheduled to be taken over a three month period.There was no additional medical information provided.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: SAFETY ENGINEERED SAMPLE NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7035800
• Report Number: 3002682307-2017-00093
• Device Sequence Number: 13771750
• Product Code: FMI
• UDI-Device Identifier: 00382903058945
• UDI-Public: 00382903058945
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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 Expiration Date: 07/31/2021
• Device Catalogue Number: 305894
• Device Lot Number: 1608002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/15/2017
• 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