MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LL W/NDL ECLIPSE 30X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305778
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll w/ndl eclipse 30x1/2 rb had a safety mechanism failure it was reported by the customer report needle stick injury.Verbatim: rcc received a complaint via email.Email(s) attached.Product concern ticket number: (b)(4).Date of incident: (b)(6) 2023 hospital: (b)(6) department: (b)(6) product: safety syringe 1cc vmid: 305778 lot number: product expiry date: n/a number of defective product(s): 1 is sample available: yes concern description: the lock mechanism on the syringe failed and we had 3 staff report needle stick injury.
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#: 305778, lot#: unknown.It was reported by the customer report needle stick injury.Verbatim: rcc received a complaint via email.Email(s) attached.Product concern ticket number: (b)(4).Date of incident: (b)(6) 2023.Hospital: (b)(6).Department: 2 north aciu.Product: safety syringe 1cc.Vmid: (b)(6).Lot number: product expiry date: n/a.Number of defective product(s): 1.Is sample available: yes.Concern description: the lock mechanism on the syringe failed and we had 3 staff report needle stick injury.Follow-up: - the complaint mentions 1 defective product, but 3 staff reported a needle stick injury.Can you clarify if all 3 staff members were stuck by the same needle? ¿ not sure.We have 2 different kinds, none of them were able to confirm which one they were using.But confirmed that lock mechanism was faulty.- can you confirm if the needle sticks were clean or dirty? ¿ 1 clean 2 dirty, administering insulin.- did any of the 3 staff members require medical intervention due to the needle sticks? ¿ no, they all followed protocol and are doing absolutely fine.Customer response on march 19, 2024.I don't have the used one.But i have put aside 2 samples.I will send them over today.Apologies for delay.
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 at 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 sample passed the eclipse safety shield inspection and activation/locking force functional test.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 30X1/2 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: 18628458
• Report Number: 2243072-2024-00101
• Device Sequence Number: 8067189
• Product Code: FMI
• UDI-Device Identifier: 30382903057789
• UDI-Public: (01)30382903057789
• 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): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305778
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown