MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 18 G X 1 1/2 IN.; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305766
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	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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 prior to use of a bd eclipse¿ needle 18 g x 1 1/2 in., that foreign matter was observed.The following information was provided by the initial reporter: staff members just noticed a black marking on the hub of an 18 ga, 1 ½ ¿ needle.
Event or Problem Description
It was reported that prior to use of a bd eclipse¿ needle 18 g x 1 1/2 in., that foreign matter was observed.The following information was provided by the initial reporter: staff members just noticed a black marking on the hub of an 18 ga, 1 ½ ¿ needle.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received by our quality team for evaluation.From the photo, black foreign matter was observed inside the eclipse hub.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.As the actual sample was not returned to determine the foreign matter type.Therefore, the root cause could not be established.H3 other text : see h.10.

• Brand Name: BD ECLIPSE¿ NEEDLE 18 G X 1 1/2 IN.
• 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: 13656375
• Report Number: 8041187-2022-00107
• Device Sequence Number: 12106336
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: 30382903057666
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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 Model Number: 305766
• Device Catalogue Number: 305766
• Device Lot Number: 1272165
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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