MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNSPECIFIED BD¿ CATHETER

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Additional initial reporter phone#: (b)(6).Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.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: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Rationale: no sample, lot, or batch provided.

Event Description

It was reported that unspecified bd¿ catheter broke off inside the patient.This was discovered during use.The following information was provided by the initial reporter: patient returns to hospital reporting foreign body on right hand back and local pain.Ultrasonography performed and presence of intravenous foreign body of approximately 2.1cm.Reported that for the removal of the material a minor surgery was performed at the site with subsequent suture.No hospitalization required.The material removed seems to be vialon.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9134681
• MDR Text Key: 204732061
• Report Number: 9610048-2019-00297
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention