MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305764
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd eclipse¿ needle unit package was torn.The following information was provided by the initial reporter: "for the 2 boxes, the quantity is only 99pcs each.There is a shortage of 1 item in each box; the other box contains 1 defective (tear).Short - 2 boxes (100ea) - lot 3011955.Damage - 1 box (100ea) - lot 3011955.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd eclipse¿ needle unit package was torn.The following information was provided by the initial reporter: "for the 2 boxes, the quantity is only 99pcs each.There is a shortage of 1 item in each box; the other box contains 1 defective (tear).Short - 2 boxes (100ea) - lot 3011955.Damage - 1 box (100ea) - lot 3011955".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 5 photos submitted for evaluation.The reported issues of short count and packaged damaged / defective / other were confirmed upon inspection of the sample photos.Analysis of the sample photos showed that one blister was missing at the corner and the packaging was damaged on one of the samples.Bd determined that the cause of the failure was related to our manufacturing process during loading of the products into the carton.An action plan has been proposed to address this root cause.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Additional Manufacturer Narrative
Based on the device history record review, no abnormality was observed during the production of the affected batch.Current control there is a visual inspection on damaged package at the qa outgoing inspection per mqa-052/e and visual inspection on damaged package (holes/slits/tear) at the packaging in-process inspection per mfg-043/l.Based on the received photos and available information of 1 unit blister missing from a box.Showing that the 1 out 5 unit in a sheet could be drop off from the secondary packaging process before package into shipper carton box.Eclipse manufacturing process was review from secondary packaging operation.Probable root cause for the missing and damaged product could be occurred at the stack insert driver loading of 5pcs in sheet into the carton box.This could be due to when eclipse needle 5pcs in a sheet is not placed flat during insertion into carton.Thus, the corner of the blister will be hit again the side guide resulting damaged the package or tear off missing (refer to attachment c).Action had been taken to modify and extend the bottom guide plate to support the blister to ensure the ¿flatness¿ during insertion to carton on 27 sep 2023 (refer to attachment d).
Event or Problem Description
For the 2 boxes, the quantity is only (b)(4) each.There is a shortage of 1 item in each box; the other box contains 1 defective (tear).Short - 2 boxes (100ea) - lot 3011955.Damage - 1 box (100ea) - lot 3011955.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17579932
• Report Number: 8041187-2023-00449
• Device Sequence Number: 8222914
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: (01)30382903057642
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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: 3011955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 11/27/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/02/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown