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

Catalog Number 367324

Device Problem Expiration Date Error (2528)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

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 the bd vacutainer winged safety push button blood collection set coa received had the wrong expiration date.The expiration date should have read 08/31/2019 and not 8/30/2019.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd had received a copy of the certificate of conformance (coa) from the customer facility for investigation.The coa provided by the customer as well as the coa in bd's system was reviewed and it was determined that the incident lot expiration date was incorrect as it did not match with the correct expiration date on the product labelling.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.Bd had initiated further investigation relating to this issue and the root cause has been identified.As a result, actions have been taken to correct the issue (i.E., the incident lot expiration date on the coa was corrected).Investigation conclusion: based on evaluation of the coa, the customer¿s indicated failure mode for an incorrect indicant lot expiration date was observed.The investigation also determined that there was no issue found with the product as it was correctly labelled.Root cause description: based on the investigation, the most likely root cause was identified to be a manufacturer data entry error.As a result, bd has corrected the incorrect incident lot expiration date on the coa.Rationale: 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 PUSH BUTTON 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
• MDR Report Key: 7290925
• MDR Text Key: 101006609
• Report Number: 1710034-2018-00048
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: 50382903673242
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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: 7237761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other