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

Model Number	305782
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse¿ syringe had a stain in the barrel.The following information was provided by the initial reporter: verbatim: there is stain in the barrel without open the package.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary.No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that the bd eclipse¿ syringe had a stain in the barrel.The following information was provided by the initial reporter: verbatim: there is stain in the barrel without open the package.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected molded barrel and syringe batches.The embedded foreign matter on the barrel collar is due to flapper seal wear and tear at the material hopper bin (refer to figure 2 in attachment b).This causes the residue from the flapper seal to mix with the resin in the material hopper, hence causing the defect.Action had been taken to add in the yearly preventive maintenance to replace the flapper seal on 11 apr 2023.The affected batch was produced before the action implementation date.
Event or Problem Description
There is stain in the barrel without open the package.

• Brand Name: BD ECLIPSE¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17334456
• Report Number: 8041187-2023-00346
• Device Sequence Number: 15107495
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: (01)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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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 Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 2251945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 11/27/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/17/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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