MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE WITH NEEDLE

Catalog Number 301940

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd syringe¿ with needle package was discolored before use.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: it was found the package discolored before using.There are several products in every two boxes with this problem.

Manufacturer Narrative

Investigation: bd has reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Bd has been provided with a picture of the affected samples.After analyzing the picture of the affected sample provided to the manufacturing site for evaluation, we could see the reported yellowed film of the blister and confirm the reported issue.The burnt film was produced in the sealing die during the primary packaging process.The sealing process works with temperatures around 150ºc, for that reason there is a water refrigeration system to avoid damaging the unit package.We conclude that a punctual failure in that system, produced an ineffective refrigeration of the sealing die, so during a stoppage of the machine, the film of the blister gets burnt and produced the reported issue.

Event Description

It was reported that bd syringe¿ with needle package was discolored before use.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: it was found the package discolored before using.There are several products in every two boxes with this problem.

• Brand Name: BD SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8540051
• MDR Text Key: 142903572
• Report Number: 3002682307-2019-00258
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 301940
• Device Lot Number: 1803215
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other