MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE; 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	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer: bd was initially made aware of this complaint on 2021-10-18.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2021-11-18 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe).Pma / 510(k)#: k161170 (needle).Investigation summary: one photo and two samples with sealed packaging were received by our quality team for evaluation.One sample was not manufactured at the tuas manufacturing plant.From the photo and the sample, stopper poor assembly was observed.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.From the sample, the team observed poor assembly between the stopper and the plunger.The probable root cause could be that the stopper was not properly seated on the lower tooling resulting in the nonconformance.There is a vision system at the assembly machine which can detect and auto-reject such nonconformances.The returned sample was challenged at the assembly vision system and was able to be rejected at the 180-degree point of view.Therefore, the nonconformance could have been escapees resulting it to flow to the next process.A feasibility study will be conducted to cover the 360-degree point of view to detect the nonconformance.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 10 bd luer-lok¿ syringes with detachable bd eclipse¿ needle had misaligned stoppers.The following information was provided by the initial reporter: "the syringe is too slippery to apply force when operating with gloves".Via bd investigation: "from the sample, the team observed poor assembly between the stopper and the plunger.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12870798
• Report Number: 8041187-2021-01005
• Device Sequence Number: 6025574
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: 30382903057826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H10
• 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
• Report Date (Section B): 11/24/2021

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 Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 0329123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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