MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305786
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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 syr 10ml ll w/ndl eclipse 22x1-1/2 rb stopper disconnected from the plunger.The following information was provided by the initial reporter: disconnect between stopper and plunger.
Event or Problem Description
It was reported that syr 10ml ll w/ndl eclipse 22x1-1/2 rb stopper disconnected from the plunger.The following information was provided by the initial reporter: disconnect between stopper and plunger.
Additional Manufacturer Narrative
H6: investigation summary: one photo and one sample were received by our quality team for evaluation.From the photo, the plunger is observed to be separated from the stopper.The sample was subjected to visual inspection and the team observed that the stopper is touching the barrel roof and the plunger is separated from the stopper.No short molding was observed, and no abnormalities were observed on the stopper.A manual simulation to observe any poor assembly for the stopper and plunger was conducted and no poor assembly was observed.A manual simulation to observed if a stopper poor assembly could result in detachment was conducted and no detachment between the stopper and plunger was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The syringe assembly process was reviewed.Based on the returned sample evaluation, the stopper was found to be touching the roof and the plunger was separated from the barrel.In the case of separation was due to stopper poor assembly to the plunger, it will be auto rejected by the vision system.In addition, the manual simulations did not show poor assembly or and no detachment was observed during withdrawal.After the vision system, the assembled parts proceed to the leak test station, and in the case of the stopper touching the roof and plunger detaches, the part would fail the leak test and be auto rejected.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h10.

• Brand Name: SYR 10ML LL W/NDL ECLIPSE 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11586623
• Report Number: 8041187-2021-00224
• Device Sequence Number: 2955940
• Product Code: FMI
• UDI-Device Identifier: 00382903057863
• UDI-Public: 00382903057863
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 11/30/2025
• Device Catalogue Number: 305786
• Device Lot Number: 0329105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1