MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BRAND SST¿ II PLASTIC TUBES WITH CONVENTIONAL STOPPER; BLOOD COLLECTION TUBE

Catalog Number 367520

Device Problem Defective Device (2588)

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

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Results: preanalytical systems received one (1) sample and six (6) photos from the customer facility for investigation.Bdj conducted drawing test with colored water and confirmed the tube drew the water.Based on the visual inspection/evaluation of the sample and photos, bd pas observed a crack on the inside wall of the tube.The manufacturing records were reviewed for the incident lot and no issues were identified.Conclusion: confirmed complaint: no definitive root cause could be established for the reported defect.

Event Description

It was reported that there was an internal defect in a bd vacutainer® brand sst¿ ii plastic tubes with conventional stopper.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® BRAND SST¿ II PLASTIC TUBES WITH CONVENTIONAL STOPPER
• Type of Device: BLOOD COLLECTION TUBE
• 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: 7085328
• MDR Text Key: 94812950
• Report Number: 9617032-2017-00361
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 367520
• Device Lot Number: 6112703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2016
• 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