MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 3ML LUER-LOK SYRINGE

Catalog Number 990174

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter fax #: (b)(6).Investigation summary: photos received for investigation.Through the analysis of the photo sent by the customer, it is not possible to observe the incident of stained packaging or wrinkled packaging, but a quality notification that may be related to the incident was evidenced.Furthermore, the analysis of the batch history, maintenance records and quality notifications were verified.A quality notification was observed for the batch that could potentially be related to the crushed packaging incident.The wrinkled packaging may have been caused by handling the packaging in the rework.In this way, bd confirms the claim for this incident.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: the analysis of the batch history (dhr), maintenance records and quality notifications were verified.A qn ((b)(4)) was observed for the batch that could potentially be related to the crushed packaging incident.The qn was not opened for the claimed failure, but as there was a need for rework in the batch, the wrinkled packaging may have been caused by handling the packaging in the rework.In this way, bd confirms the claim for this incident.It was not possible to observe the stained packaging through the photo sent by the customer.The incident identified from this complaint will be monitored for trend assessment.

Event Description

It was reported that 23 bd plastipak¿ 3ml luer-lok¿ syringes experienced liquid transfer through the top web.The following information was provided by the initial reporter: i request the exchange of the product below because the packaging is damaged/wrinkled making it impossible to sell.23 blisters are wrinkled and stained, this material does not undergo adjustment and invoice box with (b)(4).For product replacement purposes (23 units), confirm that it can be done according to the information below.Yes.Were any of the 23 packages damaged to the point of being opened? was there any evidence of loss of sterility in the product? no.

• Brand Name: BD PLASTIPAK 3ML LUER-LOK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12351571
• MDR Text Key: 267734560
• Report Number: 3003916417-2021-00211
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990174
• Device Lot Number: 0357385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1