MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364960

Device Problem Off-Label Use (1494)

Patient Problem Swelling/ Edema (4577)

Event Date 01/31/2022

Event Type  Injury  

Manufacturer Narrative

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 when using the bd vacutainer® blood collection tubes for microbiological studies, the user experienced inflammation.The following information was provided by the initial reporter.The customer stated: it was reported that plasma was injected into the patients face and her face swelled up.Customer called to report that they used tube #364960 to extract prp, she said they draw the blood and spin it down and then inject it into the patients face, the patients instantly had swelling in the face.She wad prescribed prednisone but she was still very swollen.

Manufacturer Narrative

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 when using the bd vacutainer® blood collection tubes for microbiological studies, the user experienced inflammation.The following information was provided by the initial reporter.The customer stated: it was reported that plasma was injected into the patients face and her face swelled up.Customer called to report that they used tube (b)(4) to extract prp, she said they draw the blood and spin it down and then inject it into the patients face, the patients instantly had swelling in the face.She wad prescribed prednisone but she was still very swollen.

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by visual examination and no issues were observed as all samples met specifications.This product is not intended for platelet-rich plasma (prp) injections.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed.This product is not intended for platelet-rich plasma (prp) injections.

Event Description

It was reported when using the bd vacutainer® blood collection tubes for microbiological studies, the user experienced inflammation.The following information was provided by the initial reporter.The customer stated: it was reported that plasma was injected into the patients face and her face swelled up.Customer called to report that they used tube #364960 to extract prp, she said they draw the blood and spin it down and then inject it into the patients face, the patients instantly had swelling in the face.She wad prescribed prednisone but she was still very swollen.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13486927
• MDR Text Key: 285355608
• Report Number: 1917413-2022-00061
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903649600
• UDI-Public: 00382903649600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 364960
• Device Lot Number: 1040883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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): Other
• Patient Sex: Female