MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Model Number	305782
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse¿ needle 23 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: foreign matter.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since we were unable to review the sample for evaluation.A device history review was conducted for lot number 1274981.H3 other text : see h10.
Event or Problem Description
It was reported while using bd eclipse¿ needle 23 g x 1 in.With detachable 3 ml bd luer-lok¿ syringe foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: foreign matter.

• Brand Name: BD ECLIPSE¿ NEEDLE 23 G X 1 IN. WITH DETACHABLE 3 ML BD LUER-LOK¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• 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: 16281011
• Report Number: 8041187-2023-00040
• Device Sequence Number: 6132106
• Product Code: FMF
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 09/30/2026
• Device Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 1274981
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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