MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® SINGLE USE HOLDER; BLOOD SPECIMEN COLLECTION SET.

Catalog Number 364815

Device Problem Cut In Material (2454)

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

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

Results: a photo was received and inspected showing no defect.A sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.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 the bd vacutainer® single use holder had a cut edge.No serious injury or medical intervention reported.

Manufacturer Narrative

The initial mdr was submitted with the 510k number listed as n/a.It is corrected to read pre-amendment.

• Brand Name: BD VACUTAINER® SINGLE USE HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION SET.
• 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: 7068218
• MDR Text Key: 93615021
• Report Number: 1917413-2017-00241
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903648153
• UDI-Public: 00382903648153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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,Followup
• Report Date: 01/24/2018

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 Catalogue Number: 364815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 04/06/2016
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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