MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367354

Device Problem Product Quality Problem (1506)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

(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 that the tubes in the bd vacutainer® push button blood collection set with pre-attached holder were popping off the needle. No serious injury or medical intervention was reported.

Manufacturer Narrative

Bd received samples from the customer facility for investigation. The samples were tested and the customer's indicated failure mode for tube push off 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. Based on evaluation of the customer samples, the customer¿s indicated failure mode for tube push-off 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.

Event Description

It was reported that the tubes in the bd vacutainer push button blood collection set with pre-attached holder were popping off the needle. No serious injury or medical intervention was reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7704149
• MDR Text Key: 114701688
• Report Number: 1024879-2018-00381
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K011984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 367354
• Device Lot Number: 8012801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/19/2018 Patient Sequence Number: 1