MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13X75 MM 3 ML BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE; SPECIMEN COLLECTION TUBE

Catalog Number 366703

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation: investigation summary: bd received photos from the customer facility for investigation.The customer photos were evaluated and the customer¿s indicated failure mode of incorrect stopper color with the incident lot was observed.A review of the device history record was completed for the incident lot number and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode of incorrect stopper color with the incident lot was observed.Upon review of the photos, samples did not meet the required specifications.Root cause description: based on the investigation, the root cause / potential root cause for the incorrect color was determined to be related to the manufacturing process.

Event Description

It was reported that a 13x75 mm 3 ml bd vacutainer® plus tube.Clear bd hemogard¿ closure has material code of some material and the stopper of another.

• Brand Name: 13X75 MM 3 ML BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE
• Type of Device: SPECIMEN COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6956184
• MDR Text Key: 90567365
• Report Number: 1917413-2017-00259
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 366703
• Device Lot Number: 6216982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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