MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl eclipse 25x1 rb leaked it was reported by customer that bd eclipse syringe and needle.Needle changed to bdsafety slide 25gx1" needle.When securing needle to hub of syringe, threads stripped.Needle continued to turn (no excessive force used).When phn pushed up on plunger, most of contents leaked out at hub.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip report.Incident or problem information.Ahs mdip reference number (id):(b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2024.Site name/location: (b)(4).Level of harm: no effect - did not reach patient - detected before use or does not touch person during use.Ahs optional report to cmdsnet (health canada): incident details: vaccine drawn up in combo bd eclipse syringe and needle.Needle changed to bdsafety slide 25gx1" needle.When securing needle to hub of syringe, threads stripped.Needle continued to turn (no excessive force used).When phn pushed up on plunger, most of contents leaked out at hub.Previously have had issued with using these needles on prefilled vaccines and vaccine leaking out at hub as well (report filed at that time) who was affected? no person affected.Frequency of problem: first time.Device information.Device name/description: needle hypodermic safety 25ga x 1 in / syringe 3ml with needle safety 25ga x 1 in manufacturer: becton dickinson canada inc.Manufacturer code/model: 305916 / 305787.Serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): 2027-09-30 / 31-may-26.Supplier: (b)(4).Supplier catalogue number: 308-305916 / 308-305787.Was the device retained? no.
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: 305787, batch: 1176439.It was reported by customer that bd eclipse syringe and needle.Needle changed to bdsafety slide 25gx1" needle.When securing needle to hub of syringe, threads stripped.Needle continued to turn (no excessive force used).When phn pushed up on plunger, most of contents leaked out at hub.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip report.Incident or problem information.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): 2024-01-23.Site name/location: (b)(6) health centre.Level of harm: no effect - did not reach patient - detected before use or does not touch person during use.Ahs optional report to cmdsnet ((b)(6)): incident details: vaccine drawn up in combo bd eclipse syringe and needle.Needle changed to bdsafety slide 25gx1" needle.When securing needle to hub of syringe, threads stripped.Needle continued to turn (no excessive force used).When phn pushed up on plunger, most of contents leaked out at hub.Previously have had issued with using these needles on prefilled vaccines and vaccine leaking out at hub as well (report filed at that time).Who was affected? no person affected.Frequency of problem: first time.Device information: device name/description: needle hypodermic safety 25ga x 1 in / syringe 3ml with needle safety 25ga x 1 in manufacturer: becton dickinson canada inc.Manufacturer code/model: 305916 / 305787.Serial or lot number: (b)(6) / 1176439.Device expiry date (yyyy-mm-dd): 2027-09-30 / 31-may-26.Supplier: (b)(4).Supplier catalogue number: 308-305916 / 308-305787.Was the device retained? no.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is an inspection on hub leak test assembly at the qa outgoing 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.H3 other text : see h10 manufacture narrative.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1
• 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: 18728109
• Report Number: 2243072-2024-00185
• Device Sequence Number: 20410830
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: (01)30382903057871
• 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): 03/25/2024

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: 05/31/2026
• Device Catalogue Number: 305787
• Device Lot Number: 1176439
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown