MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and 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).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration 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.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ catheter iv line did not flush during use while the catheter was "completely advanced".The iv line was disconnected but still unable to be flushed with saline, and the iv was removed.Upon removing the line, a "string like" blood clot came from the catheter tip.The following information was provided by the initial reporter: "iv was inserted and advanced into vein.Blood return was not observed after needle removed, so catheter was pulled back until complete blood return was obtained.Catheter was then advanced completely.Iv line was attached and fluid did not flow to flush catheter.Iv line disconnected and saline flush attached.Unable to flush iv with saline flush, at which time practioner decided to remove iv.Upon removing iv a string like blood clot was observed coming from the tip of the catheter.Total time from iv insertion to observation of the clot was estimated 2-3 minutes.".

Event Description

It was reported that the unspecified bd¿ catheter iv line did not flush during use while the catheter was "completely advanced".The iv line was disconnected but still unable to be flushed with saline, and the iv was removed.Upon removing the line, a "string like" blood clot came from the catheter tip.The following information was provided by the initial reporter: "iv was inserted and advanced into vein.Blood return was not observed after needle removed, so catheter was pulled back until complete blood return was obtained.Catheter was then advanced completely.Iv line was attached and fluid did not flow to flush catheter.Iv line disconnected and saline flush attached.Unable to flush iv with saline flush, at which time practioner decided to remove iv.Updon removing iv a string like blood clot was observed coming from the tip of the catheter.Total time from iv insertion to observation of the clot was estimated 2-3 minutes".

Manufacturer Narrative

H.6.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.H3 other text : see section h.10.

• Brand Name: UNSPECIFIED BD¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8876386
• MDR Text Key: 154038636
• Report Number: 2243072-2019-01645
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 DA