MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 18x1-1/2 rb safety mechanism failed it was reported by the customer that safety guard snaped attempting to put back on needle ,no guard available.Verbatim: rcc received a complaint via email.Email(s) attached.Cat# of product being complained: bd305766.Description of product: needle eclipse 18gx1.5in use ll syr sp=pk 100/pk 12pk/c.Complaint category: fail to function / defective.Reportable: no.Incident date: (b)(6) 2023.Details of complaint (reported issue): safety guard snaped attempting to put back on needle ,no guard available.Complaint noticed: during / after use.Problem frequency: 1st time.Customer exposure: patient injury: no.Has health canada been informed? unknown.Qty affected: 1 ea.Samples available? no.Is customer requesting an rga?: no.Return qty:.
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
Material#: bd305766, lot#: 2336576.It was reported by the customer that safety guard snapped attempting to put back on needle ,no guard available.Verbatim: rcc received a complaint via email.Email(s) attached.Chc complaint reference #: (b)(4) hospital complaint reference #: (b)(4).Customer (hospital) name: healthcare mat mgmt serv.Customer address: (b)(6).Correspondence language: english.Cat# of product being complained: bd305766.Description of product: needle eclipse 18gx1.5in use ll syr sp=pk 100/pk 12pk/c.Lot or s/n: (b)(6).Complaint category: fail to function / defective reportable: no.Incident date: (b)(6) 2023.Hospital complaint reference #: (b)(4).Details of complaint (reported issue): safety guard snapped attempting to put back on needle ,no guard available.Complaint noticed: during / after use.Problem frequency: 1st time.Customer exposure: patient injury: no.Has health canada been informed? unknown.Qty affected: 1 ea.Samples available? no.Is customer requesting an rga?: no.Return qty:.
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 18X1-1/2 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18455461
• Report Number: 2243072-2024-00006
• Device Sequence Number: 3087983
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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 Catalogue Number: 305766
• Device Lot Number: 2336576
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown