MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 RB

Catalog Number	305787
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl eclipse 25x1 rb needle clogged / blocked it was reported by customer that batch of needle have a lot of resistance verbatim#: rcc received a complaint via phone.Pir attached.Batch of needle have a lot of resistance.Ref: 305787.Lot: 1301551.Has samples available for investigation, would like a replacements for box.
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 4 representative samples submitted for evaluation.The reported issue of needle clogged/ blocked not was confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.No clogged needles were observed.The root cause could not be determined as the defect was not replicated.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.
Event or Problem Description
Material#: 305787, batch number#: 1301551.It was reported by customer that batch of needle have a lot of resistance verbatim#: rcc received a complaint via phone.Pir attached.Batch of needle have a lot of resistance.Ref: (b)(4).Lot: 1301551.Has samples available for investigation, would like a replacements for box.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1 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: 21037174
• Report Number: 2243072-2024-01269
• Device Sequence Number: 20731770
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: (01)00382903057870(11)211028(17)261031(10)1301551
• Combination Product (Y/N): N
• 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): 01/21/2025

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: 1301551
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown