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

Catalog Number	305780
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll w/ndl eclipse 25x5/8 rb safety mechanism failed.It was reported by customer that it seems that we have new heparin syringes.A nurse had told me she used a heparin syringe and in attempting engage the safety mechanism, it failed and broke off.The safety mechanism breaks off at the hinge.Let me know if you need more information from me.Verbatim: complaint received via email(s) attached."it seems that we have new heparin syringes.A nurse had told me she used a heparin syringe and in attempting engage the safety mechanism, it failed and broke off.The safety mechanism breaks off at the hinge.Let me know if you need more information from me.".
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of safety shield activation failure was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.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.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 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; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20163731
• Report Number: 2243072-2024-00954
• Device Sequence Number: 7282397
• Product Code: FMI
• UDI-Device Identifier: 00382903057801
• UDI-Public: (01)00382903057801
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/19/2024

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: Health Professional
• Device Catalogue Number: 305780
• Device Lot Number: 4084133
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown