MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Swelling (2091)

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 unspecified bd¿ catheter leaked.The following information was provided by the initial reporter: during removing, the nurse found that the child's arm was swollen due to leakage.Treated with magnesium sulfate by hot compress.

Manufacturer Narrative

The changes are as follow: medical device lot #: unknown.

Event Description

It was reported that unspecified bd¿ catheter leaked.The following information was provided by the initial reporter: during removing, the nurse found that the child's arm was swollen due to leakage.Treated with magnesium sulfate by hot compress.

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, photos, valid lot, or material number were provided.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that unspecified bd¿ catheter leaked.The following information was provided by the initial reporter: during removing, the nurse found that the child's arm was swollen due to leakage.Treated with magnesium sulfate by hot compress.

• Brand Name: UNSPECIFIED BD¿ CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8618017
• MDR Text Key: 145501431
• Report Number: 2243072-2019-00953
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2019

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 04/26/2019; 04/26/2019
• Supplement Dates FDA Received: 05/17/2019; 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other