MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 362781

Device Problem Leak/Splash (1354)

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

Event Date 04/28/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® cpt¿ nc: 0.45 ml ficoll¿: 1.0ml stopper pulled out.This was discovered during use.The following information was provided by the initial reporter: material no: 362781, batch no: 9058507.It was reported that during r&d testing in (b)(4), instances were identified where the 2nd stopper pullout force for some tubes did not meet our specification.The minimum and mean force were below specification during r&d testing in (b)(4), we have identified instances where the 2nd stopper pullout force for some tubes did not meet our specification.(the 2nd pullout force is the force to remove the stopper after it has been removed and reinserted into the filled tube.) the specific product sku and batch numbers where this occurred are listed below.As the test requestor i review the data to make the assessment regarding the passing or failing of the test data so the awareness dates below reflect my review of the data sheets and identification of failing results.On (b)(6) 2019, 13 jun 2019, 362781, 9058507, minimum and mean force below specification.

Manufacturer Narrative

H.6.Investigation summary: retention samples were selected from bd inventory for evaluation and testing and upon completion, no issues were observed relating to stopper pull out as all samples met specifications.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 retain samples,the customer¿s indicated failure mode for stopper pull out 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 retain 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.H3 other text : see section h.10.

Event Description

It was reported that bd vacutainer® cpt¿ nc: 0.45 ml ficoll¿: 1.0ml stopper pulled out.This was discovered during use.The following information was provided by the initial reporter: material no: 362781, batch no: 9058507.It was reported that during r&d testing in franklin lakes, instances were identified where the 2nd stopper pullout force for some tubes did not meet our specification.The minimum and mean force were below specification.During r&d testing in franklin lakes, we have identified instances where the 2nd stopper pullout force for some tubes did not meet our specification.(the 2nd pullout force is the force to remove the stopper after it has been removed and reinserted into the filled tube.) the specific product sku and batch numbers where this occurred are listed below.As the test requestor i review the data to make the assessment regarding the passing or failing of the test data so the awareness dates below reflect my review of the data sheets and identification of failing results.(b)(6) 2019, 362781, 9058507, minimum and mean force below specification.

• Brand Name: BD VACUTAINER® CPT¿ NC: 0.45 ML FICOLL¿: 1.0ML
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8749642
• MDR Text Key: 150168639
• Report Number: 1917413-2019-01682
• Device Sequence Number: 1
• Product Code: JCF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 362781
• Device Lot Number: 9058507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other