MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PLUS PLASTIC SST TUBE.; BLOOD SPECIMEN COLLECTION DEVICE.

Catalog Number 367977

Device Problem Component Falling (1105)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Results: an actual sample was not returned for evaluation.Samples from the same lot received and evaluated showing no defect.Conclusion: without actual sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Capa (b)(4) has been opened to document the investigation path and corrective/preventative actions taken to remediate this defect.

Event Description

It was reported that the tops of the 13 x 100 mm 3.0 ml bd vacutainer® plus plastic sst tube fall off in centrifuge and when removing them from centrifuge.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE.
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE.
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7077176
• MDR Text Key: 93896986
• Report Number: 1024879-2017-00833
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679775
• UDI-Public: 382903679775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 367977
• Device Lot Number: 6015533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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