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

Catalog Number 366703

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as 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 tube cracked when frozen.No injury no medical intervention.

• Brand Name: 13X75 MM 3 ML 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: 7077242
• MDR Text Key: 94303671
• Report Number: 1917413-2017-00315
• 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: 11/06/2017

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: 01/31/2017
• Device Catalogue Number: 366703
• Device Lot Number: 5175912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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