MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ SYRINGE; PISTON SYRINGE

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	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd eclipse¿ syringe had a stain on the needle.The following information was provided by the initial reporter: verbatim: there is stain on the needle when opening 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 bd eclipse¿ syringe had a stain on the needle.The following information was provided by the initial reporter: verbatim: there is stain on the needle when opening the package.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the samples.Analysis of the sample showed small black embedded foreign matter on the safety shield.The black embedded foreign matter was scattered in the safety shield.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.No long pauses happened during production.Any short stops of the molding machine will trigger an alarm, and the production technician will perform manual purging to remove common defects like short molding.Based on the review of the returned samples, it is believed the defect was not caused by pauses in production.There was no heater change on the mold during production.Unblocking of affected cavity was needed before or during the production run.When the cavity is blocked, this can cause the cavity to overheat.After unblocking, insufficient purging will result in yellowish colored safety shield and brown embedded foreign matter.However, this does not match with the returned samples, where the safety shield is still pink in color and embedded foreign matter is black.No similar complaints have been received for embedded foreign matter and this lot.Based on the available information, this is an isolated incident.The probable cause could be contaminants in the resin or color concentrates, where during the injection molding process the contaminants became embedded and scattered everywhere in the safety shield.Awareness of this defect has been raised to the resin and color concentrates supplier.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
There is stain on the needle when opening the package.

• Brand Name: BD ECLIPSE¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• 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: 17335264
• Report Number: 8041187-2023-00347
• Device Sequence Number: 6477635
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: (01)30382903057826
• Combination Product (Y/N): Y
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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: 2332403
• 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; 11/10/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/17/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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