MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number 366703

Device Problem Break (1069)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for damaged rubber membrane on the tube with the incident lot was observed.Photos were also returned showing the reported defect.A review of the manufacturing records was completed for the incident lot and no issues were identified.Due to the severity ad occurrence rate, no capa will be opened.We will continue to monitor this defect for tracking and trending purposes.

Event Description

It was reported that 13x75 mm 3 ml bd vacutainer® plus tube.Clear bd hemogard¿ closure had a damaged rubber membrane on the tube.No injury or medical intervention.

• Brand Name: BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE
• Type of Device: BLOOD 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: 7080965
• MDR Text Key: 94797018
• Report Number: 1917413-2017-00316
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• 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: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 366703
• Device Lot Number: 5210569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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