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

Catalog Number 381123

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that there was a sterile breach of several bd angiocath¿ iv catheter packages.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Bd was able to verify the customer complaint for the claimed defect.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.The complaint was verified by analyzing the sample.Although not certain, 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 to change suppliers to one which does not use lacquer as an adhesive.

Event Description

It was reported that there was a sterile breach of several bd angiocath iv catheter packages.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that there was a sterile breach of several bd angiocath iv catheter packages.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields.

• 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: 7606621
• MDR Text Key: 111741369
• Report Number: 9610048-2018-00071
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903811237
• UDI-Public: 30382903811237
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 381123
• Device Lot Number: 4310390
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other