MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® WINGED BLOOD COLLECTION SET

Catalog Number 367324

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 during use of the bd vacutainer® winged safety push button blood collection ¿the back plastic sheath (back safety button) detached from the push-button hub during blood collection.The cannula withdrew, blood was spraying.The wings and plastic holder were hanging loosely.The needle was exposed/unprotected and therefore there would have been the risk of needle stick injury.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for front/rear barrel separation with the incident lot was not observed as all product specifications were met.Visual/microscopic evaluation revealed no physical-mechanical damage on any of the components of the samples.Physical testing was also conducted and no issues relating to the front and rear barrel separating were observed.A review of the device history record was completed for the incident lot 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.Based on evaluation of the customer samples, the customer¿s indicated failure mode for front/rear barrel separation with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.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 BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7358948
• MDR Text Key: 103408186
• Report Number: 1710034-2018-00126
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: 50382903673242
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K030573
• 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,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 367324
• Device Lot Number: 7223997
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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