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

Catalog Number	305778
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd syringe 1ml ll w/ndl eclipse 30x1/2 rb safety mechanism failed it was reported by the customer that post safety engagement.Verbatim: rcc received a complaint via email.Email(s) attached.Please see attachment with sbar and photos.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 3 photos and 1 representative sample submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no damages or defects observed.The sample passed the safety shield inspection and the activation/ locking force test.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.Current controls include a visual inspection for broken cannula catch/cannula lock pin at the safety shield molding in-process inspection; fail hook inner diameter 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 quality assurance outgoing inspection; and visual inspection of damage pivot pin at the packaging in-process inspection.
Event or Problem Description
Materials#: 305778 batch#: 2311914.It was reported by the customer that post safety engagement.Verbatim: rcc received a complaint via email.Catalog#: 305778.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 30X1/2 RB
• Common Device Name: SYRINGE
• 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: 19173963
• Report Number: 2243072-2024-00564
• Device Sequence Number: 7938319
• Product Code: FMI
• UDI-Device Identifier: 30382903057789
• UDI-Public: (01)30382903057789
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: Other
• Device Catalogue Number: 305778
• Device Lot Number: 2311914
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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