MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 365072

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

There is no medical device type for this device as it is manufactured outside the us and not sold in the us.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(6).Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for (b)(4) with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.

Event Description

It was reported that bd vacutainer® sst¿ ii advance blood collection tubes had gel globules in the sst gel.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7454296
• MDR Text Key: 106705886
• Report Number: 9617032-2018-00662
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 365072
• Device Lot Number: 6124632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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