MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305780
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd luer-lok¿ syringe with bd eclipse¿ needle had a defective stopper.The following information was provided by the initial reporter: "distorted stopper.Incident occur: before use.".
Additional Manufacturer Narrative
Pma / 510(k)#: k941562 (syringe).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary one photo was received by our quality team for evaluation.From the photo, the team observed that the plunger is withdrawn to the retainer ring and there are signs of distortion at the top stopper edge.A review of the internal manufacturing device records and raw material history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 and the quality team there has conducted a supplemental investigation on this nonconformance.A potential root cause for the jammed stopper defect is associated with the assembly process.H3 other text : see h10.
Event or Problem Description
It was reported bd luer-lok¿ syringe with bd eclipse¿ needle had a defective stopper.The following information was provided by the initial reporter: "distorted stopper.Incident occur: before use.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes d.10.Returned to manufacturer on: 20-jul-2022 h.6.Investigation summary: one photo and one sample were received by our quality team for evaluation.From the photo, the team observed that the plunger is withdrawn to the retainer ring and there are signs of distortion at the top stopper edge.The sample was subjected to visual inspection and the top edge of the stopper is observed to be distorted downwards inside the syringe barrel.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 and the quality team there has conducted a supplemental investigation on this nonconformance.A potential root cause for the jammed stopper defect is associated with the assembly process.H3 other text : see h.10.
Event or Problem Description
It was reported bd luer-lok¿ syringe with bd eclipse¿ needle had a defective stopper.The following information was provided by the initial reporter: "distorted stopper.Incident occur: before use.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE
• 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: 14354952
• Report Number: 8041187-2022-00246
• Device Sequence Number: 3987924
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: 30382903057802
• 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,Followup
• Report Date (Section B): 08/15/2022

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: 08/31/2026
• Device Model Number: 305780
• Device Catalogue Number: 305780
• Device Lot Number: 1237349
• 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: 04/20/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 08/15/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/24/2022; 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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