MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE; 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	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: pma / 510(k)#: k980987.Medical device type: fmf.Common device name: piston syringe.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 bd eclipse¿ needle 23 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe a defect in scale marking was discovered in 129 syringes.The following information was provided by the initial reporter: scale skew.
Additional Manufacturer Narrative
H.6.Investigation: one photo and 129 samples in sealed packaging were received by our quality team for evaluation.From the photo, slant scale marking was observed in reference to the bd logo and pink tape edge.The team observed a slight skew in the scale marking on the syringe barrel for 64 of the received samples.These 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.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 while using bd eclipse¿ needle 23 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe a defect in scale marking was discovered in 129 syringes.The following information was provided by the initial reporter: scale skew.

• Brand Name: BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML 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: 13338485
• Report Number: 8041187-2022-00032
• Device Sequence Number: 11780700
• 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: 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: 08/31/2026
• Device Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 1237355
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/14/2022
• 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