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

Catalog Number	305769
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	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that black foreign matter was found in the cap of the bd eclipse¿ needle.The following information was provided by the initial reporter, translated from chinese: "there is a black foreign matter in the cap of the safety needle.".
Event or Problem Description
It was reported that black foreign matter was found in the cap of the bd eclipse¿ needle.The following information was provided by the initial reporter, translated from chinese: "there is a black foreign matter in the cap of the safety needle.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 30-sep-2022.H6: investigation summary: one sample in open packaging were received by our quality team for evaluation.The sample was subjected to visual inspection.The team observed seven small black embedded pieces of foreign matter on the safety shield.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.Per the preventative maintenance record, the injection screw was cleaned before the production of the affected safety shield batches.There was no heater change on the mold / press during production and there was no unblocking of the affected molding cavity before or during the production run.Based on the sample evaluations, there were several pieces of black embedded foreign matter on the safety shield.No similar complaints have been received on embedded foreign matter associated with the safety shield batches and only one piece of safety shield is affected for the reported batch, per available information.It is therefore suspected that there may be loose contaminants from the resin which became embedded during the molding process.A foreign matter separator has already been installed in the molding hopper to filter out contaminants.

• 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: 15580948
• Report Number: 8041187-2022-00590
• Device Sequence Number: 15077624
• Product Code: FMI
• UDI-Device Identifier: 00382903057696
• UDI-Public: (01)00382903057696
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/25/2022

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: 09/30/2026
• Device Catalogue Number: 305769
• Device Lot Number: 1274625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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