MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381112

Device Problem Problem with Sterilization (1596)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2018

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 with the use of the bd angiocath¿ iv catheter there was an issue with sterile breach.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received on 10/31/2018, one unused unit in slightly opened package from catalog number 381112, lot number 7027714.The sample received were analyzed at bd sandy where it was confirmed opened package.This is the first complaint for package seal integrity poor/questionable for lot number 7027714, product code 381112.Dhr review: a review of the device history record was completed for final product catalog #381112 lot 7027714 manufactured from 16-feb-17at 18-feb-17 in multivac r530-2 package machine.This lot was reviewed regarding the following tests: - adhesive transfer test, which is evidence through mark of the sealing film, the adhesiveness of the paper was transferred to the bottom web, assuring the sealing of the product; - packaging leakage test, which is a test that challenges the integrity of the sealing, as the holes, sealing channels or any other breach of the sealing that could compromise the sterilization of the product; - width and sealing test, which evaluates the parameter according internally specified that the width of the seal should be greater than 3.2 mm also were all within specifications.- all parameters of the sealing machine were within that specified for the claimed lot.Based on this analysis, no records were found that could lead to the incident in question.Qn/ ncmr review: there are no quality notification (qn) or nonconformity report of "package seal integrity poor/questionable¿ or anything that could lead to be related to this complaint.Bd was able to verify the reported issue of an opened package.There were no records of failure/ integrity of the seal in the batch history analysis and in the records of non-conformity or quality notification for the claimed batch.It should be noted that the sample demonstrated the sealing mark on the film, which shows that sealing occurred normally during the sealing process.It was not possible to determine the root cause of this defect, due to the absence of nonconformities related to this defect and due to the lack of objective evidence in the device history record of packaging claimed, such as: the packaging parameters are within the specifications, the adhesive transfer mark on the film, which proves that the product has been properly sealed during the packaging of the product.As a possible cause of this defect would be a failure in the adhesiveness of the paper with the film due to the lacquer contained in the paper from the supplier.It was determined as an action to exchange the adhesiveness of the paper.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

Event Description

It was reported with the use of the bd angiocath¿ iv catheter there was an issue with sterile breach.There was no report of injury or medical intervention.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8023981
• MDR Text Key: 125767795
• Report Number: 9610048-2018-00183
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903811121
• UDI-Public: 30382903811121
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 381112
• Device Lot Number: 7027714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other