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

Catalog 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	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was found in the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.The following information was provided by the initial reporter: "there¿s a undetermined substance found in the syringe".
Additional Manufacturer Narrative
Device evaluated by mfr: 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: d10: device available for eval yes, d10: returned to manufacturer on: 26-jan-2023.H6: investigation summary: our quality engineer inspected the 4 photos and 1 sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample and photos.Analysis of the sample and photos showed that there was brown foreign matter in the syringe barrel.Bd determined that the cause of the failure was contaminants in the resin where during injection molding process the contaminants became embedded to the syringe barrel.A notification has been sent to our supplier of this incidence.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported that foreign matter was found in the bd luer-lok¿ syringe with detachable bd eclipse¿ needle.The following information was provided by the initial reporter: "there¿s a undetermined substance found in the syringe".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH DETACHABLE 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: 16164993
• Report Number: 8041187-2022-00810
• Device Sequence Number: 20584303
• Product Code: FMI
• UDI-Device Identifier: 00382903057825
• UDI-Public: 00382903057825
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/01/2023

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 Catalogue Number: 305782
• Device Lot Number: 2228932
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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