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

Catalog Number 368856

Device Problem Device Slipped (1584)

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

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Bd received samples from the customer facility for investigation.The samples were evaluated by simulated draw and then physically examined for loose caps, and the customers' indicated failure mode for with the incident lot was not observed.A review of the dhr identified no issues relating to the reported defect.Unconfirmed complaint.Bd was unable to duplicate or confirm the customers¿ indicated failure mode because the defect was not evident in the testing of the returned samples.

Event Description

It was reported that there are problems with the lavender bd hemogard¿ closures not being secure to bd vacutainer® k2edta plus plastic tubes (13x75 mm,3.0 ml).No serious injury, blood to mucous membrane exposure or medical intervention was reported.

• Brand Name: BD VACUTAINER® K2EDTA PLUS PLASTIC TUBE, LAVENDER BD HEMOGARD¿
• 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: 7097217
• MDR Text Key: 94935554
• Report Number: 9617032-2017-00364
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K981013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 368856
• Device Lot Number: 6235586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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