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

Catalog Number 305759

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that the box of bd eclipse¿ safe skin injection needles listed them as 5/8 inches instead of 1 inch needles, but had the same lot/expiry on both the box and packaging units.The following information was provided by the initial reporter: "mislabeled box of 100 needles.The label read size 5/8 inch but the needles inside were size 1 inch and had the same lot and expiry date on the actual needles as on the box.No adverse event reported.".

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-oct-2023.H6: investigation summary 99samples were received by our quality team for evaluation.The topweb from the returned samples was indicated to be 305761 (needle eclipse 25g x1) instead of 305759 (needle eclipse 25g x5/8).The variable print containing the udi number, manufacturing date, expiration date and lot number were correct for all affected products in accordance with the associated catalogue number.The cannula of the eclipse product was determined to be a 5/8¿ sized cannula.During the device history review, it was observed that during production, four pieces of topweb (catalog 305761) and two pieces of topweb (catalog 305761) was pasted.Regarding the two pieces of topweb (catalog 305761) nonconformance, the production technician was interviewed and confirmed that the correct topweb (catalog 305759) was used.The discrepancy was due to an incorrect method of topweb collection.A project has been initiated to address this nonconformance.The probable root cause has been identified as the production technician did not verify the top web information during inspection, there is no detection of the top web by the vision system, and there is no designated area for return top web material.From the project, re-training on the inspection procedure has been conducted to the eclipse team, the inspection form has been updated to include inspection for pre-printed topweb, a vision system has been installed on the packaging line to detect an incorrect top web, and a designated area for top web return material has been identified.

Event Description

It was reported that the box of bd eclipse¿ safe skin injection needles listed them as 5/8 inches instead of 1 inch needles, but had the same lot/expiry on both the box and packaging units.The following information was provided by the initial reporter: "mislabeled box of 100 needles.The label read size 5/8 inch but the needles inside were size 1 inch and had the same lot and expiry date on the actual needles as on the box.No adverse event reported".

• Brand Name: BD ECLIPSE¿ SAFE SKIN INJECTION NEEDLE
• Type of Device: 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: 17714231
• MDR Text Key: 323001429
• Report Number: 8041187-2023-00480
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: 00382903057597
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305759
• Device Lot Number: 0115011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1