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

Model Number	305780
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple device names/types and 510k numbers reported to be involved.Additional information below: medical device type: fmf.Common device name: piston syringe.Pma / 510(k)#: k941562.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the stoppers in 2 bd eclipse¿ needle with detachable bd luer-lok¿ syringes were defective/damaged.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "distorted stopper".
Event or Problem Description
It was reported that the stoppers in 2 bd eclipse¿ needle with detachable bd luer-lok¿ syringes were defective/damaged.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "distorted stopper.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 14-apr-2022.H.6.Investigation: two photos, three samples in open packaging, and one sample in sealed packaging were received by our quality team for evaluation.From the first photo, a slight downwards deformation on the edge of the topper for two 1ml syringe products were observed.From the second photo, the team observed black ink covering the whole surface area of the syringe barrel until the retainer ring from approximately 0.9ml scale marking onwards.The samples were subjected to visual inspection.For the sample in the sealed packaging, black ink was observed covering one side of the syringe barrel surface approximately 0.9ml scale marking onwards, no distorted stopper was observed.For one of the three samples in open packaging, no distorted stopper was observed but black ink was observed covering the whole surface area of the syringe barrel approximately 0.85ml scale marking onwards.Two of the three samples in open packaging were observed with the top edge of the stopper distorted downwards inside the syringe barrel and no ink stain on the 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 1 ml syringe part is manufactured at bd canaan and the bd canaan quality team has performed a supplemental investigation.The potential root cause for the jammed stopper defect is associated with the assembly process.The potential root cause for the smeared print defect is associated with the marking process.There was a quality notification for this issue raised and the affected product was scrapped.However, it is possible a limited number of pieces with this condition were able to escape detection.

• Brand Name: BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE
• 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: 14135141
• Report Number: 8041187-2022-00196
• Device Sequence Number: 4237641
• 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
• Report Date (Section B): 05/31/2022

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: 03/24/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 06/14/2022
• 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