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	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stopper was distorted and the scale markings were misaligned on the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.This event occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: "distorted stopper, syringe scale is skewed.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
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 stopper was distorted and the scale markings were misaligned on the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.This event occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: "distorted stopper, syringe scale is skewed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 1/14/2022.H6: investigation: one photo and five samples were received by our quality team for evaluation.From the photo, slant scale marking was observed in reference to the bd logo and stopper edge.The team was unable to observe a distorted stopper as the photo is unclear.All samples were subjected to visual inspection.No distorted stopper was observed on the returned samples.Slight skewed scale marking was observed on all five returned samples.The samples were subjected to volumetric testing and passed.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 root cause of the distorted stopper could not be determined as no distorted stopper was observed.Current controls to prevent this nonconformance include a vision system at the 3ml line to check for product with stopper mis-assembly and will be auto-rejected at the reject station.The vision system is also challenged every shift with accordance to the assembly process daily checklist.Although there is a slight skew in the scale marking, it does not affect the dosage of the solution as the volumetric test is within specification.An investigation was conducted at the syringe apex printing machine to find the cause of the skewed printing.The printing pad set up plays an important role to achieve good printing on the barrel.With a good printing pad set up, consistent printing is achieved as the printing pad is secured on the printing drum.It was understood that any slight skewed printing was deemed acceptable during routine inspection as this defect does not affect the volumetric test.Therefore, the root cause is attributed to the inattentiveness of the slight skewed printing defect by the production technician during printing pad set-up and by both the manufacturing and quality assurance associate during routine inspection.
Event or Problem Description
It was reported that the stopper was distorted and the scale markings were misaligned on the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.This event occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: "distorted stopper, syringe scale is skewed.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13294361
• Report Number: 8041187-2022-00017
• Device Sequence Number: 4554849
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 1237355
• 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: 12/24/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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