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

Catalog Number	305780
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd eclipse¿ needle with detachable bd luer-lok¿ syringe experienced foreign matter in the barrel.The following information was provided by the initial reporter, translated from mandarin chinese to english: there are foreign matter in the barrel.
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 3 photos and 5 samples submitted for evaluation.The reported issues of foreign matter was confirmed upon inspection of the samples.One loose syringe was received with a severe ink ring that is 1/2" long by the flange area and an ink dot on the barrel tip that is 1/16".Another image shows a loose syringe with the ink ring and ink dot condition as described above.Potential root cause for the ink ring defect is associated with the marker process.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
Event or Problem Description
It was reported that the bd eclipse¿ needle with detachable bd luer-lok¿ syringe experienced foreign matter in the barrel.The following information was provided by the initial reporter, translated from mandarin chinese to english: there are foreign matter in the barrel.

• Brand Name: BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16261145
• Report Number: 8041187-2023-00027
• Device Sequence Number: 20529538
• Product Code: FMI
• UDI-Device Identifier: 00382903057801
• UDI-Public: 00382903057801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K941562
• 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): 03/17/2023

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 305780
• Device Lot Number: 1237349
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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