MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.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 the needle separated from the syringe.There was no report of patient impact.The following information was provided by the initial reporter: rcc received the complaint via email.I was made aware of an incident with bd eclipse needle lot # 1286868 coming unattached while attempting to collect cord blood.Have you had any other reports of this happening? i do not have the needle to send in.
Additional Manufacturer Narrative
Photo evaluation ¿ 3 photos were received for investigation (refer to attachment a).¿ from the photos, observed the cannula is detached from the hub.Sample evaluation ¿ 2 representative samples in sealed packaging were received for investigation (refer to figure 1 in attachment b).¿ the 2 samples were subjected to visual inspection to check for insufficient epoxy.The samples passed the visual inspection (refer to results in attachment b).¿ the sample then is subjected to cannula pull force test per test method (b)(4) and passed the cannula pull force test (refer to results in attachment b).Based on device history record review, no abnormality was observed during the production of the affected batches.The bulk assembled needle is purchased from bd curitiba and bd curitiba had been notified of this complaint (refer to email communication in attachment d).
Event or Problem Description
Material #: 305766.Batch #: 1286868.It was reported by the customer that bd eclipse needle coming unattached while attempting to collect cord blood.Verbatim: rcc received the complaint via email.Email(s) as attached.I was made aware of an incident with bd eclipse needle lot # 1286868 coming unattached while attempting to collect cord blood.Have you had any other reports of this happening? i do not have the needle to send in.See pictures attached.Response received on (b)(6) 2023: 1.Please confirm if there was any patient involvement? if yes, what was the patient outcome? there was no patient involvement.2.Was there any adverse event or serious injury reported? no 3.Are you able to confirm the quantity of defective needles inspected? all needles are inspected before use.Needle was found to be defective during use.4.What type of procedure was being done? umbilical cord blood collection.Removal of needle from an umbilical cord.5.Was the procedure completed as planned? no, needle broke from hub presenting a safety issue.6.Are you able to provide the date of incident? (b)(6) 2023.

• Brand Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17882645
• Report Number: 8041187-2023-00524
• Device Sequence Number: 15202255
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: 305766
• Device Lot Number: 1286868
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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