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

Catalog Number	305780
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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 clogged / blocked.It was reported by customer that they are randomly not expelling all the medication out of the syringe.Verbatim: complaint received via email(s).Email from (b)(4) distributor representative: "i have a customer with a serious problem with bd syringes.They are randomly not expelling all the medication out of the syringe.I have called bd with all this electronic responses is a worthless waste of time for me.I have been trying to connect via phone 2 times they disconnect me and by the chat on the website and they just disconnect me.The customer is.".
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
Material #: 305780 batch#: 4206669.It was reported by customer that they are randomly not expelling all the medication out of the syringe.Verbatim: complaint received via email(s) attached.Email from mckesson distributor representative: "i have a customer with a serious problem with bd syringes.They are randomly not expelling all the medication out of the syringe.I have called bd with all this electronic responses is a worthless waste of time for me.I have been trying to connect via phone 2 times they disconnect me and by the chat on the website and they just disconnect me.The customer is.".

• 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; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21032720
• Report Number: 2243072-2024-01263
• Device Sequence Number: 9155527
• Product Code: FMI
• UDI-Device Identifier: 00382903057801
• UDI-Public: (01)00382903057801(11)240822(17)290731(10)4206669
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 305780
• Device Lot Number: 4206669
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown