MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 367342

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported there was leakage around the edge of tubing of bd vacutainer® push button blood collection set.Customer stated: there was 3 separate incidents of leakage around the edge of the tubing.Batch 8344559 / material 367342 was used in all 3 incidents.2 patient involved incidents on 01-mar.No exposure, no patient identifiers.1 patient involved incident on 06-mar.Employee exposure to the eyes.Medical intervention: washing of the eyes.Patient identifier: (b)(6) female.

Event Description

It was reported there was leakage around the edge of tubing of bd vacutainer® push button blood collection set.Customer stated: there was 3 separate incidents of leakage around the edge of the tubing.Batch 8344559 / material 367342 was used in all 3 incidents.2 patient involved incidents on 01-mar.No exposure, no patient identifiers.1 patient involved incident on 06-mar.Employee exposure to the eyes.Medical intervention: washing of the eyes.Patient identifier: 40 year old female.

Manufacturer Narrative

Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for tubing leakage with the incident lot was observed.Pressurized leak testing of the customer samples was performed and no leakage was 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.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for tubing leakage with the incident lot was observed.Root cause description: 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® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8460828
• MDR Text Key: 145113143
• Report Number: 1024879-2019-00653
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 367342
• Device Lot Number: 8344559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other