MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD BLOOD TRANSFUSION SETS (WITHOUT STOPCOCKS AND/OR Y-SITE); INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Extravasation (1842)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

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.Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.The date received by manufacturer has been used for this field.Initial reporter phone # unknown.Medical device expiration date: unknown.Device manufacture date: unknown.No samples were received for investigation of complaint reference pr (b)(4) reported via post market survey; however the customer has indicated that they experienced thrombophlebitis & extravasation during use of a bd transfusion set.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.

Event Description

It was reported that while using the unspecified bd blood transfusion sets (without stopcocks and/or y-site) the clinician and/or patient experienced extravasation.The following information was provided by the initial reporter: clinician experienced: extravasation.

• Brand Name: UNSPECIFIED BD BLOOD TRANSFUSION SETS (WITHOUT STOPCOCKS AND/OR Y-SITE)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15499808
• MDR Text Key: 300759443
• Report Number: 2243072-2022-01674
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• 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