MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305767
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x1-1/2 rb safety mechanism failure (eclipse) - tuas the following information was provided by the initial reporter: it was reported by the customer that the safety came off when cnm went to use needle.Verbatim: rcc received a complaint via email.Email(s) attached.Item: bd eclipse 25 guage needle.Safety came off when cnm went to use needle.Lot number 0237462 1.Are you able to provide the date of event in format dd-mmm-yyyy? (b)(6) 2024 2.Are you able to provide the batch/lot number? 0237462 3.Was issue being described noted before, or during used? during use 4.Was there any patient involvement? no 5.Any adverse events or serious injury reported to patient or healthcare professional? no 6.What was the patient outcome? n/a 7.Was there any delay of, or change in, the course of treatment due to this event? yes, need to obtain new product, delaying care 8.What procedure was being performed? unknown 9.What medication was used in the procedure? unknown 10.Was there any medical intervention due to this event? no 11.Does a return shipping label need to be generated? if yes, kindly provide the sender¿s name and address.No note: no further information available.
Event or Problem Description
Material#: 305767, lot#: 0237462.It was reported by the customer that the safety came off when cnm went to use needle.Verbatim: rcc received a complaint via email.Email(s) attached.Item: bd eclipse 25 guage needle.Safety came off when cnm went to use needle.Lot number 0237462.1.Are you able to provide the date of event in format dd-mmm-yyyy? 08/03/2024.2.Are you able to provide the batch/lot number? 0237462.3.Was issue being described noted before, or during used? during use.4.Was there any patient involvement? no.5.Any adverse events or serious injury reported to patient or healthcare professional? no.7 was there any delay of, or change in, the course of treatment due to this event? yes.Need to obtain new product, delaying care.8.What procedure was being performed? unknown.9.What medication was used in the procedure? unknown.10.Was there any medical intervention due to this event? no.11.Does a return shipping label need to be generated? if yes, kindly provide the sender¿s name and address.No.Note: no further information available.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on broken cannula catch/cannula lock pin at the safety shield molding in-process inspection; fail hook id inspection on the eclipse hub molding in-process inspection; activation/locking force functional test, deactivation/unlocking forces functional test and eclipse safety shield inspection at the qa outgoing inspection; and visual inspection of damage pivot pin at the packaging in-process inspection.Actual root cause could not be determined as no sample were received for investigation.The complaint will be re-opened and re-investigated when sample is received.

• Brand Name: BD NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19023834
• Report Number: 2243072-2024-00490
• Device Sequence Number: 20834720
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: (01)30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 08/31/2025
• Device Catalogue Number: 305767
• Device Lot Number: 0237462
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown