MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
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 the bd needle eclipse 18x1-1/2 rb damaged or open unit package the bottom product packaging is broken.
Event or Problem Description
The bottom product packaging is broken.
Additional Manufacturer Narrative
Based on the device history record review, no abnormality was observed during the production of the affected assembled needle batch.From the returned photos, one unit blister was observed damaged.The secondary packaging operation process was reviewed.The probable root cause for the damaged package could be due to the l plate leveling bar being loose at the 2nd bucket chain station.Consequently, the l plate became uneven during the transfer of the 5-piece unit blister during stacking.As a result, the first layer of the 5-piece sheet would hit against the base of the l plate, causing parts to be damaged or cut off from the strip.There is an action in place to engage vendor to weld the leveling bar to the l plate fully which is already completed.This batch is produced before the action implementation.

• Brand Name: BD NEEDLE ECLIPSE 18X1-1/2 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: 19924364
• Report Number: 2243072-2024-00868
• Device Sequence Number: 8375516
• Product Code: FMI
• UDI-Device Identifier: 00382903057665
• UDI-Public: (01)00382903057665
• 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: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: Other
• Device Catalogue Number: 305766
• Device Lot Number: 4055228
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown