MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 25X5/8; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 305759

Device Problem Inaccurate Information (4051)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no photos or samples were received by our quality team for evaluation.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, specifically how the production technician did not verify the top web information during inspection, the lack of detection of the top web by the vision system, and the lack of a designated area for return top web material.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 600 needle eclipses 25x5/8 had incorrect label information the following information was provided by the initial reporter: the packaging labels it as 25g x 1¿ eclipse needle when it is a 25g x 5/8¿ eclipse needle.

• Brand Name: NEEDLE ECLIPSE 25X5/8
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12208086
• MDR Text Key: 264383885
• Report Number: 8041187-2021-00626
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903057598
• UDI-Public: 30382903057598
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2021

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
• Device Operator: Other
• Device Model Number: 305759
• Device Catalogue Number: 305759
• Device Lot Number: 0115011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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