MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog or a lot number could not be confirmed for this incident, and without this information we are unable to determine where the device was manufactured.(b)(4).Device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: 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 that the cannula broke in the patients forearm during use with a unspecified bd catheter.The following information was provided by the initial reporter, "cannula appears to have been broken and part of plastic tubing left in patients forearm.Staff nurse contacted myself at approximately 2150 on (b)(6) 2019 explaining she went to flush a blue cannula that was in situ and cannula had appeared to tissued.Therefore cannula was removed.When the cannula was removed it appeared that the plastic tubing has snapped from the main part of the cannula.The plastic tubing has therefore assumed to be left in the patients forearm." i contacted on call anaesthetics doctor to aid in reviewing the patient with a view to use ultrasound to try and confirm location.Anaesthetic doctor attended and used ultrasound, thought possibly could see tubing but not 100%.Therefore she advised a plain x ray.X ray completed and unable to see any radio opaque tubing.Discussed with on call surgical doctor who advised discussing with vascular at jcuh.I discussed with vascular registrar who advised discussing with on call radiologist to see if a ct would be of value.I discussed with a radiologist via nighthawk, they advised ct would not be the most useful investigation and ultrasound is best at detecting plastic foreign body.Advised if surgical team are not planning on exploratory surgery then best course of action would be to monitor overnight and get a radiologist to use ultrasound in day hours to review possible plastic foreign body and could advise on removal.Plan to monitor and seek specialist advise from radiologist in the morning.This will have implications on outcome i.E? procedure required.".

Manufacturer Narrative

H.6.Investigation summary: no customer sample or adequate information on reported lot number or material number available for sample traceability.This complaint lacks adequate information on reported lot number or material number for evaluation or review of dhr, therefore the customer complaint could not be confirmed for further investigations.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.H3 other text : see section h.10.

Event Description

It was reported that the cannula broke in the patients forearm during use with a unspecified bd catheter.The following information was provided by the initial reporter, "cannula appears to have been broken and part of plastic tubing left in patients forearm.Staff nurse contacted myself at approximately 2150 on (b)(6) 19 explaining she went to flush a blue cannula that was in situ and cannula had appeared to tissued.Therefore cannula was removed.When the cannula was removed it appeared that the plastic tubing has snapped from the main part of the cannula.The plastic tubing has therefore assumed to be left in the patients forearm." i contacted on call anaesthetics doctor to aid in reviewing the patient with a view to use ultrasound to try and confirm location.Anaesthetic doctor attended and used ultrasound, thought possibly could see tubing but not 100%.Therefore she advised a plain x ray.X ray completed and unable to see any radio opaque tubing.Discussed with on call surgical doctor who advised discussing with vascular at jcuh.I discussed with vascular registrar who advised discussing with on call radiologist to see if a ct would be of value.I discussed with a radiologist via nighthawk, they advised ct would not be the most useful investigation and ultrasound is best at detecting plastic foreign body.Advised if surgical team are not planning on exploratory surgery then best course of action would be to monitor overnight and get a radiologist to use ultrasound in day hours to review possible plastic foreign body and could advise on removal.Plan to monitor and seek specialist advise from radiologist in the morning.This will have implications on outcome i.E? procedure required.".

• Brand Name: UNSPECIFIED BD CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8880853
• MDR Text Key: 153890231
• Report Number: 2243072-2019-01661
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• 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
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention