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

Catalog Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's address is unknown:  (b)(6) usa has been used as a default.  date of event: unknown.The date received by manufacturer has been used for this field.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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.Device manufacture date: unknown.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 tubing ballooning occurred with a unspecified bd catheter.The following information was provided by the initial reporter, "i was wondering if anyone else has had any issues with iv's blowing during routine ct scans our radiology department states that they run their contrast at 3ml per sec for standard ct and 4ml per sec for cta.With that the iv's are blowing and causing a patient safety issue.Is anyone else experiencing this issue and if so what can be done to avoid this issue?".

Manufacturer Narrative

H.6.Investigation summary bd has not been provided with photos or samples to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.A device history review could not be completed as no batch number was provided.If the samples become available in the future, this record will be re-opened and analyzed accordingly.No corrective actions are required at this time.H3 other text : see section h.10.

Event Description

It was reported that tubing ballooning occurred with a unspecified bd catheter.The following information was provided by the initial reporter, "i was wondering if anyone else has had any issues with iv's blowing during routine ct scans our radiology department states that they run their contrast at 3ml per sec for standard ct and 4ml per sec for cta.With that the iv's are blowing and causing a patient safety issue.Is anyone else experiencing this issue and if so what can be done to avoid this issue?".

• 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: 9850645
• MDR Text Key: 188030456
• Report Number: 2243072-2020-00436
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other