MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® CPT¿ GLASS TUBE; BLOOD COLLECTION TUBE

Catalog Number 362780

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

The reported lot #¿s do not exist for the reported cat #.Therefore, the device manufacture and expiration dates are unknown.Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported during use of the bd vacutainer® cpt¿ glass tube the tubes are breaking during centrifugation.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received samples of incident lot number 6340898 from the customer facility for investigation.Note that samples of incident lot number 7038985 were not received for evaluation.The samples from lot 6340898 were visually evaluated and there were no defects observed with the glass that would have attributed to potential glass breakage as all product specifications were met.A review of the device history record was completed for the incident lots and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples for incident lot number 6340898, the customer¿s indicated failure mode for issues with the glass breaking 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.

• Brand Name: BD VACUTAINER® CPT¿ GLASS TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7148750
• MDR Text Key: 96018696
• Report Number: 1917413-2017-00591
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 362780
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other