MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305788
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma / 510(k)#: k980987; k161170.Investigation summary: review of dhr revealed all required challenges samples and testing was performed as per specification in according with the in-process sampling plans and out - going sampling plans.The returned photo was observed to have missing scale on the syringe.Missing scale could have probably caused by eject gate at the apex machine.The manufacturing process was reviewed.It was suspected that the eject gate at apex machine was not fully closed after pt clear machine error.This may cause the reject parts to pass through when they start running the machine.Investigation conclusion: the returned photo was observed to have missing scale on the syringe.Root cause description: missing scale could have probably caused by eject gate at the apex machine.The manufacturing process was reviewed.It was suspected that the eject gate at apex machine was not fully closed after pt clear machine error.This may cause the reject parts to pass through when they start running the machine.
Event or Problem Description
It was reported that a syringe 3ml ll w/ndl eclipse 22x1 rb had scale marking error.The following was reported, "scale missing".

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8453791
• Report Number: 8041187-2019-00252
• Device Sequence Number: 3057656
• Product Code: FMI
• UDI-Device Identifier: 30382903057888
• UDI-Public: 30382903057888
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 305788
• Device Lot Number: 7114289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other