MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305764
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
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 needle eclipse 21x1 rb tw damaged or open unit package 1bx (100ea) found damaged upon checking of stocks.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of packaging seal integrity poor/ questionable was confirmed upon inspection of the photos.The secondary packaging operation process was reviewed.The probable root cause for the missing product and damaged package could be the l plate leveling bar being loose at the second 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 be hit against the base of the l plate, causing parts to be damaged or cut off from the strip.To prevent this defect, corrective actions include engaging with the vendor to weld the leveling bar to the l plate fully.One random check will be performed to verify that all l plates have been welded accordingly.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
1bx (100ea) found damaged upon checking of stocks.

• Brand Name: BD NEEDLE ECLIPSE 21X1 RB TW
• 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: 19539986
• Report Number: 2243072-2024-00713
• Device Sequence Number: 17696316
• Product Code: FMI
• UDI-Device Identifier: 00382903057641
• UDI-Public: (01)00382903057641
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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: 305764
• Device Lot Number: 3360172
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown