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

Catalog Number 367989

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5058935.Conclusion: without a 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 for further investigation of this complaint.

Event Description

It was reported that the 13x100 mm 5.0 ml bd vacutainer® plus plastic sst tube.Gold bd hemogard¿ closure stopper was loose and came off.No injury or medical intervention.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE
• 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: 7078007
• MDR Text Key: 94409495
• Report Number: 1024879-2017-00754
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679898
• UDI-Public: 00382903679898
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023075
• 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: 10/31/2017

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: 02/29/2016
• Device Catalogue Number: 367989
• Device Lot Number: 5058935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2015
• 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