MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VACUTAINER® EDTA TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problems Thrombus (2101); No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device brand name: unknown.Medical device type: unknown.Common device name: unknown.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.Therefore, bd corporate headquarters in (b)(4) has been listed in this report.Medical device catalog#: unknown.Medical device lot#: unknown.Medical device expiration date: unknown.Unique identifier (udi) #: unknown.Device manufacture date: unknown.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.

Event Description

It was reported that an unknown device had clotting.

Event Description

It was reported that a bd vacutainer® device had clotting.

Manufacturer Narrative

Event description was changed from an "unknown" device had clotting to a "bd vacutainer®" device had clotting.Medical device brand name was changed from an "unknown" device to "bd vacutainer®".Common device name was changed from "unknown" to "blood specimen collection device".

Manufacturer Narrative

Event description was changed from an "bd vacutainer®" device had clotting to an "unspecified bd vacutainer® edta tube" device had clotting.Medical device brand name was changed from a "bd vacutainer®" device to "unspecified bd vacutainer® edta tube".

Event Description

It was reported that an unspecified bd vacutainer® edta tube had clotting.

• Brand Name: UNSPECIFIED BD VACUTAINER® EDTA TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7514795
• MDR Text Key: 241265814
• Report Number: 2243072-2018-00631
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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: 08/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other