MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® HEMOGARD¿ GLASS STERILE TUBES; BLOOD COLLECTION TUBE

Catalog Number 367716

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

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 #5251673 and no issues were identified.Dhr was reviewed.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.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.Capa (b)(4) has been opened.

Event Description

It was reported that the cap of bd vacutainer® glass sterile tubes, siliconized interior, 0.105m buffered sodium citrate, hemogard¿ closure, see thru label, 4.5.Ml draw detached after blood collection.No injury or medical intervention.

• Brand Name: BD VACUTAINER® HEMOGARD¿ GLASS STERILE TUBES
• 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: 7089322
• MDR Text Key: 94749141
• Report Number: 1917413-2017-00427
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 367716
• Device Lot Number: 5251673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• 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