MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE 23G 1IN

Catalog Number 302006

Device Problem Inaccurate Information (4051)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle 23g 1in experienced incorrect color on the device.The following information was provided by the initial reporter: needle hub color is different.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-07.H6: investigation summary one photo and one actual sample was received by our quality team for evaluation.The sample was subjected to visual inspection and a slight discoloration on the hub was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The molding process was reviewed.There were no abnormalities observed during the production of the affected batches.It is observed that the returned sample is slightly discolored with green / yellow.Based on the team¿s investigation, the sample was produced in a mold with only blue, black, and brown coloring.The actual root cause could not be determined.The probable cause could be due to the color concentrate material.This nonconformance has been reported to the color concentrate supplier for their investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the needle 23g 1in experienced incorrect color on the device.The following information was provided by the initial reporter: needle hub color is different.

• Brand Name: NEEDLE 23G 1IN
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12255110
• MDR Text Key: 264383049
• Report Number: 8041187-2021-00666
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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 Catalogue Number: 302006
• Device Lot Number: 0324712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1