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; PISTON SYRINGE

Model Number	305780
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
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 movement was diffiecult.There was no report of patient impact.The following information was provided by the initial reporter: complaint: they last order the customer received they have issue with, the barrel is jammed and cannot inject second half of the dose when they depress the syringe.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation.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 1ml syringe part is manufactured at bd canaan.The bd canaan quality team has completed a supplemental investigation on this complaint.A review of their 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.As no samples displaying the reported condition were received, a potential root cause could not be determined.
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 movement was diffiecult.There was no report of patient impact.The following information was provided by the initial reporter: complaint: they last order the customer received they have issue with, the barrel is jammed and cannot inject second half of the dose when they depress the syringe.

• 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; PISTON SYRINGE
• 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: 15686621
• Report Number: 8041187-2022-00627
• Device Sequence Number: 7384452
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: (01)30382903057802
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 11/11/2022

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 Model Number: 305780
• Device Catalogue Number: 305780
• Device Lot Number: 1300659
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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