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

Catalog Number 367986

Device Problem Hole In Material (1293)

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

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during a blood draw using a bd vacutainer® plus plastic sst tube gold bd hemogard¿ there was a hole found in the bottom of the tube.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for a small opening in the bottom of the tube (molding issue) with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for a small opening at the bottom of the tube was observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿
• 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: 7137145
• MDR Text Key: 95732202
• Report Number: 1024879-2017-01273
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K901449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 367986
• Device Lot Number: 7158897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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