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

Catalog Number	305891
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd eclipse¿ safety needle safety part became loose.The following information was provided by the initial reporter, translated from dutch to english: at an institution we have received complaints from 3 different departments that the safety part of the needle has come loose.All three reports concern product with lot number 2206002.
Event or Problem Description
It was reported that the bd eclipse¿ safety needle safety part became loose.The following information was provided by the initial reporter, translated from dutch to english: at an institution we have received complaints from 3 different departments that the safety part of the needle has come loose.All three reports concern product with lot number 2206002, see also the pictures.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided material number 305891 and lot number 2206002.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.To aid in the investigation of this issue, two (2) picture samples were provided for evaluation by our quality engineer team.Through examination of the first picture, the safety shield was observed broken at the ¿pivot¿ area (the area which is directly assembled to the hub).The broken part of the safety shield remained within the hub.Through examination of the second picture, the safety shield was not well assembled; the ¿pivot¿ was not assembled onto the hub properly.The material used to manufacture eclipse needles has been selected and tested to resist normal conditions of use.Our assembly process has a system which inspects all product for proper activation and rejects any defects identified.Every lot produced is tested for safety shield activation prior to release.At this time, an exact cause could not be determined for this incident.

• Brand Name: BD ECLIPSE¿ SAFETY NEEDLE
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 16618428
• Report Number: 3002682307-2023-00080
• Device Sequence Number: 6164850
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: 00382903058914
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305891
• Device Lot Number: 2206002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown