MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SPECIALTY TUBES BD HEMOGARD¿/CLEAR; URINE COLLECTION SET.

Catalog Number 366408

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd received representative samples from the customer facility for investigation.The actual device was not returned.The samples were evaluated and the customer's indicated failure mode for stopper pull out with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: 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® specialty tubes bd hemogard¿/clear.Became disengaged from the tube when disconnecting the transfer straw from the urine collection cup.No serious injury, no medical interventions.No mucous membrane exposure reported.

Manufacturer Narrative

The initial mdr was submitted with the incorrect medical device type.The correct type is fmh.The initial mdr was submitted with n/a as the 510k but this device is listed as exempt.

Manufacturer Narrative

The initial mdr was submitted with the incorrect device type code.The correct device type code is jka.

• Brand Name: BD VACUTAINER® SPECIALTY TUBES BD HEMOGARD¿/CLEAR
• Type of Device: URINE COLLECTION SET.
• 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: 7098136
• MDR Text Key: 94821040
• Report Number: 1024879-2017-01036
• Device Sequence Number: 1
• Product Code: FMH
• 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,Followup,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 366408
• Device Lot Number: 6328897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• 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