MAUDE Adverse Event Report: BD BD PEN NED UF SHORT 8MM 90S - 31G 5/16; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 1125247

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Boxes have crawling larvae / cocoons and actually life small moths came out of all 3 boxes.

• Brand Name: BD PEN NED UF SHORT 8MM 90S - 31G 5/16
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD
• MDR Report Key: 13093541
• MDR Text Key: 282905289
• Report Number: MW5106291
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 08290320881
• UDI-Public: 08290320881
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/21/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1125247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female