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

Catalog Number 366703

Device Problem Crack (1135)

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

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

Results: bd received 11 samples and 2 photos from the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for (b)(4) with the incident lot was observed.The returned samples showed no reported defects.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that 13x75 mm 3 ml bd vacutainer® plus tube.Clear bd hemogard¿ closure tubes were cracking after being put in the freezer.No serious injury or medical intervention reported.

• Brand Name: 13X75 MM 3 ML BD VACUTAINER® PLUS TUBE. CLEAR BD HEMOGARD¿ CLOSURE
• Type of Device: SPECIMEN STORAGE CONTAINER
• 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: 7084134
• MDR Text Key: 94517459
• Report Number: 1917413-2017-00373
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 00382903667031
• UDI-Public: 00382903667031
• 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: 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: 12/05/2017
• 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: 5210567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2015
• 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