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

Model Number	305760
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse needle with smartslip there were sterility issues.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: we found a defect on the sterility of the needles ref (b)(4).The concerned lot 2112013.We have these needles available at the pharmacy.
Event or Problem Description
It was reported while using bd eclipse needle with smartslip there were sterility issues there was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: we found a defect on the sterility of the needles ref (b)(4).The concerned lot 2112013.We have these needles available at the pharmacy.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided material number 305760 and lot number 2112013.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, one (1) picture sample was provided for evaluation by our quality engineer.Through examination of the picture, a hole was observed within the packaging paper.It is possible that the observed package damage resulted during the packaging process.In the primary packaging process, film and paper are sealed and then the secondary packaging process consists of the introduction of needle strips into the shelf cartons.A malfunction in the machinery could have taken place in which the strips were not positioned properly, resulting in this defect.

• Brand Name: BD ECLIPSE NEEDLE WITH SMARTSLIP
• 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: 17096884
• Report Number: 3002682307-2023-00153
• Device Sequence Number: 1983144
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: (01)50382903057608
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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 Model Number: 305760
• Device Catalogue Number: 305760
• Device Lot Number: 2112013
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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