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

Catalog Number 305770

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd eclipse¿ needle the safety mechanism failed and a needlestick occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: description complaint safety cap did not click properly over needle causing needle sticking accident.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number 305770 and lot number 2107013.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples of the provided lot number were obtained from the manufacturing facility for evaluation.No defects were observed with the safety mechanisms of the retained samples.It was possible to correctly activate the safety mechanisms by following the product¿s instructions for use.Based on the investigation results, an exact cause related to the needle manufacturing process could not be determined for this reported incident.Prior to product release, each lot number is tested for a final safety shield activation test.Lot number 2107013 was found to comply with all specifications.The assembly process has a system which inspects all product for proper opening and activating of safety shields and automatically rejects any defects identified.

Event Description

It was reported while using bd eclipse¿ needle the safety mechanism failed and a needlestick occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: description complaint safety cap did not click properly over needle causing needle sticking accident.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16036150
• MDR Text Key: 306068419
• Report Number: 3002682307-2022-00351
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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: Other
• Device Catalogue Number: 305770
• Device Lot Number: 2107013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention