MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305782
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd eclipse¿ needle, the device experienced leakage past the stopper.The following information was provided by the initial reporter.The customer stated: stopper leak.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 11/29/2021.H6: investigation: one used sample were received by our quality team for evaluation.From the sample, a crack line was observed on the front and back of the syringe 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 syringe assembly process was reviewed.At the syringe assembly process, there is a rotary main assembly dial.During the transfer of the syringe product to the exerciser dial, the syringe may tilt and hit against the dial side guide and cause the part to be trapped / jammed.When there is a product trapped / jammed at the side guide, it leads to the subsequent syringe to rub against the jammed product and causes damage on the barrel body and resulted in the leakage past stopper.However, if the air jet, located at the auto-reject station which used to blow off the part from dial pocket, is out of position, it will lead to poor part throw out and flow to the subsequent process.
Event or Problem Description
It was reported when using the bd eclipse¿ needle, the device experienced leakage past the stopper.The following information was provided by the initial reporter.The customer stated: stopper leak.

• Brand Name: 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: 13025086
• Report Number: 8041187-2021-01057
• Device Sequence Number: 16598364
• 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): 12/21/2021

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: 02/28/2026
• Device Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 1055832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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