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

Catalog Number 367344

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device type: jka, fpa.Common device name: blood specimen collection device; intravascular administration set.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 three bd vacutainer® push button blood collection set experienced blood spatter/leakage.The following information was provided by the customer: material no.367344, batch no.8276889.Customer left voicemail for call back.Spoke to him (b)(6) 2019.He stated "hole connecting to needle is leaking blood".This was reported 3x at 3 different locations as he manages all locations.Unused product is available for investigation.No blood exposure reported.Incident 3 of 3.

Manufacturer Narrative

Investigation: investigation summary: bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for leakage with the incident lot was not observed as all product specifications were met.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 leakage with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.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.

Event Description

It was reported that three bd vacutainer® push button blood collection set experienced blood spatter/leakage.The following information was provided by the customer: material no.367344, batch no.8276889 - customer left voicemail for call back.Spoke to him 03/21/2019.He stated "hole connecting to needle is leaking blood".This was reported 3x at 3 different locations as he manages all locations.Unused product is available for investigation.No blood exposure reported.Incident 3 of 3.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8492113
• MDR Text Key: 143304789
• Report Number: 1024879-2019-00698
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673440
• UDI-Public: 50382903673440
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 367344
• Device Lot Number: 8276889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other