MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB; 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	11/12/2024
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 3ml ll w/ndl eclipse 25x1 rb plunger rod broken / damaged.It was reported by customer that he is using item 305787; lot 4084135 and the plunger is slightly bent and the plunger is hard to push.He pushes the plunger hard to get the medication to deliver and then he ends up losing medication because of the force it takes to push the plunger.He has about 1/2 of a box left and would like replacements.Verbatim: rcc received a complaint via phone.Customer states that he is using item 305787; lot 4084135 and the plunger is slightly bent and the plunger is hard to push.He pushes the plunger hard to get the medication to deliver and then he ends up losing medication because of the force it takes to push the plunger.He has about 1/2 of a box left and would like replacements.
Additional Manufacturer Narrative
Our quality engineer inspected the photos, and 14 representative samples submitted for evaluation.The reported issue of plunger rod broken/ damaged was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.No other abnormalities were observed.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 of the defect could not be determined as the defect could not be replicated.
Event or Problem Description
Material# 305787, batch# 4084135.It was reported by customer that he is using item 305787; lot 4084135 and the plunger is slightly bent and the plunger is hard to push.He pushes the plunger hard to get the medication to deliver and then he ends up losing medication because of the force it takes to push the plunger.He has about 1/2 of a box left and would like replacements.Verbatim: rcc received a complaint via phone.Pir attached.Customer states that he is using item 305787; lot 4084135 and the plunger is slightly bent and the plunger is hard to push.He pushes the plunger hard to get the medication to deliver and then he ends up losing medication because of the force it takes to push the plunger.He has about 1/2 of a box left and would like replacements.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 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: 21086686
• Report Number: 2243072-2024-01294
• Device Sequence Number: 17867135
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: (01)00382903057870(11)240403(17)290331(10)4084135
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: CA
• 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): 01/23/2025

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: Health Professional
• Device Catalogue Number: 305787
• Device Lot Number: 4084135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown