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

Catalog Number 367986

Device Problem Device Slipped (1584)

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

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: two representative samples were returned for evaluation.Stopper creep and first/second pull-out testing was conducted on the (b)(4) samples with no defects identified.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6022905.Conclusion: 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.

Event Description

It was reported that the caps on 13x100 mm 5.0 ml bd vacutainer® plus plastic sst tube.Gold bd hemogard¿ tubes were not securely clicking when going to recap the tubes.The tops were coming off and causing a mess.There was no serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE
• Type of Device: BLOOD COLLECTION TUBE
• 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: 7078011
• MDR Text Key: 94283353
• Report Number: 1024879-2017-00766
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679867
• UDI-Public: 00382903679867
• 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: 12/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 367986
• Device Lot Number: 6022905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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