MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 30X1/2; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305757
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
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 bdneedle eclipse 30x1/2 was damaged the patient stated that she tried to put the needle on the syringe and screw it, but the piece in the screw area of the needle was broken, and then the medication was leaking.She stated that she tried to unscrew it, but the medication kept on leaking until there was no medication left in the syringe.The patient stated that she couldn¿t identify where the damage part was, all she remembered is that the damage was at the connector part of the syringe.The syringe that pairs with this needle is the bd syringe barrel, hyoak scf1mll rf prtc7025/65, bd part no.47204710.
Event or Problem Description
The patient stated that she tried to put the needle on the syringe and screw it, but the piece in the screw area of the needle was broken, and then the medication was leaking.She stated that she tried to unscrew it, but the medication kept on leaking until there was no medication left in the syringe.The patient stated that she couldn¿t identify where the damage part was, all she remembered is that the damage was at the connector part of the syringe.The syringe that pairs with this needle is the bd syringe barrel, hyoak scf1mll rf prtc7025/65, bd part no.47204710.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on broken cannula catch/cannula lock pin at the safety shield molding in-process inspection; fail hook id inspection on the eclipse hub molding in-process inspection; activation/locking force functional test, deactivation/unlocking forces functional test and eclipse safety shield inspection at the qa outgoing inspection; and visual inspection of damage pivot pin at the packaging in-process inspection.Actual root cause could not be determined as actual sample was not returned investigation.The complaint will be re-opened and re-investigated when sample is received.

• Brand Name: BD NEEDLE ECLIPSE 30X1/2
• 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: 20304584
• Report Number: 2243072-2024-00996
• Device Sequence Number: 7624028
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: (01)00382903057573(11)211228(17)261231(10)1362838
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 305757
• Device Lot Number: 1362838
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown