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	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse¿ needle 25 g x 5/8 in.With detachable 1 ml bd luer-lok¿ syringe experienced a broken barrel.The following information was provided by the initial reporter: broken barrel.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-nov-2022.H.6.Investigation summary: one photo and one sample were received by our quality team for evaluation.From the photo, the plunger rod was observed to be damaged.The sample was subjected to visual inspection and the plunger rod was observed to be damaged.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 line was reviewed and there are no contact points in the machine that could damage the plunger rod.The 1ml syringe part is supplied from bd canaan and their quality team has completed a supplemental investigation on this.The potential root cause for the damaged plunger defect is associated with the assembly process.It is likely that the plunger thumb rest was mangled as a part of a jam in the plunger feed system and was inadvertently assembled.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd eclipse¿ needle 25 g x 5/8 in.With detachable 1 ml bd luer-lok¿ syringe experienced a broken barrel.The following information was provided by the initial reporter: broken barrel.

• 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: 15694966
• Report Number: 8041187-2022-00629
• Device Sequence Number: 20538571
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 1328213
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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