MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) 13X75 MM 3.5 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number 367983

Device Problem Device Slipped (1584)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the stoppers from 13x75 mm 3.5 ml bd vacutainer® plus plastic sst tube.Gold bd hemogard¿ closures were popping off.In one instance the blood sprayed the operator in the face.No medical intervention reported.

Manufacturer Narrative

Investigation: investigation summary: bd requested samples and/or photos of the product, but none were provided by the customer for evaluation.A review of the device history record was completed for the incident lot number and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.A capa was initiated for complaints relating to stopper pop off.The capa investigation is still on-going and further improvements will be made as the potential causes of this issue are identified.Investigation conclusion: a capa was initiated for this issue in order to establish a root cause and implement necessary corrective actions.Root cause description: a capa was initiated for this issue in order to establish a root cause and implement necessary corrective actions.(b)(4).Rationale: based on an assessment of severity and frequency, it was determined that a corrective action (capa) is required at this time.A capa was initiated to determine the root cause associated with stopper pop off and implement corrective actions in order to reduce/mitigate further occurrence of this issue.The capa investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

• Brand Name: 13X75 MM 3.5 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE
• Type of Device: BLOOD COLLECTION TUBE
• 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: 6859668
• MDR Text Key: 85907592
• Report Number: 1024879-2017-00148
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K023075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 367983
• Device Lot Number: 7069879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• 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