MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB

Catalog Number	305780
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
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 syringe 1ml ll w/ndl eclipse 25x5/8 rb needle through shield.It was reported by customer that package had an extra exposed needle sticking out of the sealed package.Verbatim: rcc received a complaint via email.Email(s) attached.Saturday evening customer went to draw up heparin and the package had an extra exposed needle sticking out of the sealed package, clean needle however she almost got stuck.
Event or Problem Description
Material # 305780 ; batch # 3330672 it was reported by customer that package had an extra exposed needle sticking out of the sealed package verbatim: rcc received a complaint via email.Email(s) attached.Saturday evening customer went to draw up heparin and the package had an extra exposed needle sticking out of the sealed package, clean needle however she almost got stuck item: 305780.Serial/lot number: (b)(6).Po : (b)(4).
Additional Manufacturer Narrative
From the returned photo, observed that the extra component did not have safety shield and needle shield.A stimulation was done at the packaging machine and observed that eclipse needle without needle shield cannot be picked up by the robot arm before loading to the table jig.The unloaded parts will then be pushed off the rack by the next row of incoming racks.At the next process, stimulation was done and observed that needle without needle shield cannot be picked up by the pick and place arm before loading into the bottom web.Based on device history record review, no abnormality was observed during the production of the affected batches.Probable root cause could be due to human handling by the production technician (pt) at the vision system station.When clearing parts at the pick and placed station, the pt could have unknowingly misplaced the needle without shield part into the bin near the vision system.At the vision system station, when pt placing parts from the bin on to the bottom web, the stray part could have dropped on to the bottom web.No similar complaints received on extra component leading to damaged package and only 1 piece of product is affected.Furthermore, current control there is a visual inspection for extra component at the qa outgoing inspection per and visual inspection for extra component at the packaging in-process inspection, the complaint trend will be tracked and monitored.Proposed action plan: 1 re-train on housekeeping and cleaning of equipment - eclipse.Effectiveness check plan: 1 conduct one interview sessions to four production technicians, verified that the associates understood the need to do proper housekeeping.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 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; suzhou industrial park; singapore 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19288175
• Report Number: 2243072-2024-00614
• Device Sequence Number: 15239412
• Product Code: FMI
• UDI-Device Identifier: 30382903057802
• UDI-Public: (01)30382903057802
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 06/14/2024

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: 305780
• Device Lot Number: 3330672
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown