MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 23X1 RB; 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	12/22/2021
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 while using syringe 3ml ll w/ndl eclipse 23x1 rb the scale markings were imprecise.There was no report of patient impact.The following information was provided by the initial reporter: syringe scale is skewed.
Event or Problem Description
It was reported while using syringe 3ml ll w/ndl eclipse 23x1 rb the scale markings were imprecise.There was no report of patient impact.The following information was provided by the initial reporter: syringe scale is skewed.
Additional Manufacturer Narrative
H.6.Investigation: one photo and one sample were received by our quality team for evaluation.From the photo, slant scale marking taking reference from the bd logo and retainer ring of the syringe was observed.The sample was subjected to visual inspection.Slight skewed scale marking on the syringe barrel was observed.The sample was 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.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.

• Brand Name: 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: 13283276
• Report Number: 8041187-2022-00004
• Device Sequence Number: 14670742
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: 30382903057826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• 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): 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: 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: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/12/2022
• 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