MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305782
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
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 bd syringe 3ml ll w/ndl eclipse 23x1 rb had a bent tip.The following information was provided by the initial reporter: "broken adapter".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for evaluation?: yes.D.9.Returned to manufacturer on: 12/9/2021 h.6.Investigation: one photo and one sample with open package was received by our quality team for evaluation.From the photo, damage was observed on the hub collar.The sample was subjected to visual inspection and a dent was observed at the eclipse hub collar.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 assembly process was reviewed.The station that contacts the eclipse hub collar would be at the discharge station.The probable root cause could be that there were stay parts at the discharge station which was not effectively cleared off during housekeeping.The stray parts and the subsequent incoming parts reaching the discharge station were then jammed and continuously hit each other, eventually damaging the hub collar and then falling into the good part bin.
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl eclipse 23x1 rb had a bent tip.The following information was provided by the initial reporter: "broken adapter".

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 23X1 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12964477
• Report Number: 8041187-2021-01031
• Device Sequence Number: 4179785
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: 30382903057826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• 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): 01/13/2022

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: 05/31/2026
• Device Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 1147619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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