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 Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

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

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned for evaluation.There were no related quality notifications.All process and final inspections comply with specification requirements.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.(b)(4).

Event Description

It was reported that the top of a 13x75 mm 3 ml bd vacutainer® plus tube.Clear bd hemogard¿ closure was loose and came off before use.Ther was no report of injury or medical intervention.

Manufacturer Narrative

Record was re-opened for review as part of capa (b)(4).A dhr review was conducted.Investigation summary: manufacturing records review: the manufacturing records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

• 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: 6727001
• MDR Text Key: 80647623
• Report Number: 1917413-2017-00074
• 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
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 366703
• Device Lot Number: 6279828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other