MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 20ML LL; PISTON SYRINGE

Catalog Number 300629

Device Problem Fungus in Device Environment (2316)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd plastipak¿ 20ml ll smells of mold.There was no report of patient impact.The following information was provided by the initial reporter: clinics have reported a smell of mold from the affected product.Purchaser has been to the warehouse and can confirm this.No information regarding adverse events.

Manufacturer Narrative

H6: investigation summary : no photos or physical samples that display the reported condition were available for investigation.All products labeled as "sterile" are certified for release, the package must be unopened and undamaged.The sterilization for this product is compliant with iso 11135 guidelines and the product has been evaluated in accordance with iso 10993 "biological evaluation of medical devices" and adheres to all relevant sections.There have been no changes in the manufacturing process or materials used to manufacture this product.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information, we were unable to determine the root cause for the alleged defect at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.H3 other text : see h10.

Event Description

It was reported that bd plastipak¿ 20ml ll smells of mold.There was no report of patient impact.The following information was provided by the initial reporter: clinics have reported a smell of mold from the affected product.Purchaser has been to the warehouse and can confirm this.No information regarding adverse events.

• Brand Name: BD PLASTIPAK 20ML LL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11822995
• MDR Text Key: 253488953
• Report Number: 3003152976-2021-00262
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1