MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE

Catalog Number 367986

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Insert (1316)

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

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for device malfunction with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that a 13x100 mm 5.0 ml bd vacutainer® plus plastic sst tube gold bd hemogard¿ closure needle would not properly insert to fill tube during draw.The yellow cap completely snapped off while in the vacutainer holder.When an attempt was made to remove the tube, it was noticed that the rubber stopper was not in the tube correctly.No serious injury or medical intervention was reported.

• Brand Name: 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE GOLD BD HEMOGARD¿ CLOSURE
• Type of Device: VACUTAINER
• 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: 7088366
• MDR Text Key: 94522300
• Report Number: 1024879-2017-00304
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679867
• UDI-Public: 00382903679867
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023075
• 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
• Report Date: 11/25/2017

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: 11/30/2016
• Device Catalogue Number: 367986
• Device Lot Number: 5316737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• 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