MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that syringe 3ml ll w/ndl eclipse 25x1 rb plunger came off.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that syringe was unable to draw up liquid, and the plunger came off.
Additional Manufacturer Narrative
Investigation summary: one sample without packaging was received by our quality team for evaluation.The sample was subjected to visual inspection and the team observed that the stopper was separated from the plunger.The plunger of the sample was subjected to visual inspection and had observed short molding at the plunger head.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 separation between the stopper and plunger is due to short molding at the plunger head.Short molding on the plunger head could have happened during machine start-up.The initial shots with short molding defect after machine start-up were not effectively purged and removed before conveyed to the subsequent process.The production technicians were retrained to purge out at least seven shots before machine start up after this batch was manufactured.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl eclipse 25x1 rb plunger came off.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that syringe was unable to draw up liquid, and the plunger came off.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12599172
• Report Number: 8041187-2021-00891
• Device Sequence Number: 3585976
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: 00382903057870
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/28/2021

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: 02/28/2026
• Device Catalogue Number: 305787
• Device Lot Number: 1069644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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