MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2EDTA PLASTIC TUBE, LAVENDER BD HEMOGARD¿; EDTA PLASTIC SERUM TUBE

Catalog Number 368856

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field of (b)(6) 2016.(b)(6).Results: bd received 31 samples from the customer facility for investigation.24 samples were tested by x-value for stopper separation, remaining 7 were drawn with horse blood and allowed to sit.All samples passed testing and could not confirm customers' indicated failure mode of stopper creep out or separation issues.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined.Bd was not able to duplicate or confirm the customers¿ indicated failure mode.

Event Description

It was reported that the lavender bd hemogard¿ stopper came off from a 13x75 mm, 3.0 ml, bd vacutainer® k2edta plus plastic tube, after use.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® K2EDTA PLASTIC TUBE, LAVENDER BD HEMOGARD¿
• Type of Device: EDTA PLASTIC SERUM 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: 7088568
• MDR Text Key: 94815348
• Report Number: 9617032-2017-00326
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K981013
• 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: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 368856
• Device Lot Number: 6057560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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