MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305765
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse¿ needle packaging had tiny tears which exposed the needle outside the environment.The following information was provided by the initial reporter: during the packaging process, it was identified by the operators that the tyvek side of the needle packaging had tiny tears which exposed the needle to the outside environment.
Additional Manufacturer Narrative
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¿ needle packaging had tiny tears which exposed the needle outside the environment.The following information was provided by the initial reporter: during the packaging process, it was identified by the operators that the tyvek side of the needle packaging had tiny tears which exposed the needle to the outside environment.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 20-dec-2022.H6: investigation summary: our quality engineer inspected the 1 photo and 2 samples submitted for evaluation.The reported issue of package damaged / defective / other was confirmed upon inspection of the samples.Analysis of the sample showed that the packaging of one of the returned samples was damaged.From the sample evaluation, observed that the safety shield was protruding the topweb causing the package to be damaged due shallow pocket.Suspect that the pocket is deformed due to material shrinkage causing the shallow pocket.The probable cause is due to machine stoppages when the production technicians need to attend to machine related issue or trouble shooting.Dhr for packaged needle (pn) was performed for batch 0090373 (catalog 305765).

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16032009
• Report Number: 8041187-2022-00763
• Device Sequence Number: 7193355
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: 00382903057658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 305765
• Device Lot Number: 0090373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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