MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 30 G BD ECLIPSE¿ NEEDLE ONLY 1/2 IN. LUER LOCK HUB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305757
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
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 using a 30 g bd eclipse¿ needle only 1/2 in.Luer lock hub, the needle was broken.The following information was provided by the initial reporter: the customer said the needle is broken.
Additional Manufacturer Narrative
H6: investigation summary two photos were received by our quality team for evaluation.From the photos, the team did not observe the reported defect of needle is broken.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.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h10.
Event or Problem Description
It was reported that prior to using a 30 g bd eclipse¿ needle only 1/2 in.Luer lock hub, the needle was broken.The following information was provided by the initial reporter: the customer said the needle is broken.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 21-oct-2022.Investigation summary two photos and one activated eclipse sample in open packaging were received by our quality team for evaluation.From the photo, the team was not able to observe a broken needle.The sample was subjected to visual inspection.No broken / damaged cannula was observed.No abnormality was observed on the cannula bevel.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.Current quality controls include a visual inspection for damaged components performed at the quality assurance outgoing inspection and a visual inspection for damaged needles performed at the in-process inspection.Based on the sample evaluation, no broken / damaged cannulas or abnormalities were observed.Therefore, the root cause cannot be established.
Event or Problem Description
It was reported that prior to using a 30 g bd eclipse¿ needle only 1/2 in.Luer lock hub, the needle was broken.The following information was provided by the initial reporter: the customer said the needle is broken.

• Brand Name: 30 G BD ECLIPSE¿ NEEDLE ONLY 1/2 IN. LUER LOCK HUB
• 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: 14651797
• Report Number: 8041187-2022-00295
• Device Sequence Number: 5574757
• Product Code: FMI
• UDI-Device Identifier: 30382903057574
• UDI-Public: 30382903057574
• 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,Followup
• Report Date (Section B): 10/27/2022

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: 12/31/2023
• Device Model Number: 305757
• Device Catalogue Number: 305757
• Device Lot Number: 8362592
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 10/27/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/13/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2018
• 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