MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 25 G X 5/8 IN. WITH DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305780
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: 510k#: k161170.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 25 g x 5/8 in.With detachable 1 ml bd luer-lok¿ syringe the plunger broke.The following information was provided by the initial reporter: plunger broken.Incident occur: before use.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes d.10.Returned to manufacturer on: 20-jul-2022 h.6.Investigation summary: one photo and one sample were received by our quality team for evaluation.From the photo, the team observed a broken plunger thumb press.The sample was subjected to visual inspection and the plunger thumb press was observed to be broken.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The packaging machine was reviewed and there is no direct contact with the plunger thumb press at the machine that can break the thumb press.The 1 ml syringe part is manufactured at bd canaan and the quality team there has conducted a supplemental investigation on this nonconformance.A potential root cause for the damaged plunger rod defect is associated with the assembly process.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd eclipse¿ needle 25 g x 5/8 in.With detachable 1 ml bd luer-lok¿ syringe the plunger broke.The following information was provided by the initial reporter: plunger broken incident occur: before use.

• Brand Name: BD ECLIPSE¿ NEEDLE 25 G X 5/8 IN. WITH DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE
• 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: 14596593
• Report Number: 8041187-2022-00284
• Device Sequence Number: 12113501
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K941562
• 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): 08/15/2022

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: 09/30/2026
• Device Model Number: 305780
• Device Catalogue Number: 305780
• Device Lot Number: 1274995
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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