MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number 301229

Device Problem Packaging Problem (3007)

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

Event Date 07/21/2021

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 bd plastipak¿ luer-lok¿ syringe blister pack was discolored.The following information was provided by the initial reporter, translated from (b)(6) to english: "the syringe was taken out of the blister for the preparation of cytostatics and nourishment for infants, no contamination occurred.It was noticed that the blister is dirty on the outside and in the inside.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-16.H6: investigation summary: sample and photos received for investigation, upon visual inspection of the sample it can be seen foreign matter inside the blister.The foreign matter found is a piece of film from unitary packaging stained with grease, the black grease also stained the paper from the unitary packaging.Once examined, the foreign matter attached to the barrel can be confirmed to be plastic from the bag where bulk product is packaged.This defect can be produced in primary packaging process if film gets stuck in the chains of the equipment that locates the product along the process.A device history review was performed for lot 2010002, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe blister pack was discolored.The following information was provided by the initial reporter, translated from german to english: "the syringe was taken out of the blister for the preparation of cytostatics and nourishment for infants, no contamination occurred.It was noticed that the blister is dirty on the outside and in the inside.".

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12346327
• MDR Text Key: 267447961
• Report Number: 3003152976-2021-00487
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301229
• Device Lot Number: 2010002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1