MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® WINGED SAFETY PBCS WITH TUBING AND ADAPTER; BLOOD COLLECTION SET

Catalog Number 367342

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd vacutainer® winged safety push button blood collection set with tubing and luer adapter leaked during/post use.There was no report of exposure to mucous membranes, injury or medical interventions.

Manufacturer Narrative

Bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for blood splatter with the incident lot was observed.However, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Bd recommends activation of the device while the needle is still in the venipuncture site.Activation of the device after the needle is removed from the site should be performed away from self and others, since external blood droplets may result.Based on evaluation of the customer photos, the customer¿s indicated failure mode for blood splatter with the incident lot was observed.Based on the investigation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® WINGED SAFETY PBCS WITH TUBING AND ADAPTER
• Type of Device: BLOOD 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: 7152438
• MDR Text Key: 96117262
• Report Number: 1024879-2017-01318
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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