MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BRAND SST II TUBES CONTAINING SILICA AND GEL 8.5ML; BLOOD COLLECTION TUBE

Catalog Number 367528

Device Problems Defective Device (2588); Device Markings/Labelling Problem (2911)

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

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the printing on a bd vacutainer® brand sst ii tubes containing silica and gel 8.5 ml was defective, and "missing prints and a part of print".There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for defective printing with the incident lot was observed.Additionally, evaluation of the customer samples was performed and tubes with defective printing were 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 nonconformance during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for defective printing with the incident lot was observed.Additionally, evaluation of the customer samples was conducted and defective prinitng was observed.Root cause description: based on the investigation, the most likely root cause of the reported defect is that the banding mat picked up insufficient ink which resulted in parts of the information failing to print on the tubes.This may have been due to the mat being damaged and or the banding ink reservoir running low.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.

• Brand Name: BD VACUTAINER® BRAND SST II TUBES CONTAINING SILICA AND GEL 8.5ML
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7309429
• MDR Text Key: 101494289
• Report Number: 9617032-2018-00030
• Device Sequence Number: 1
• Product Code: JKA
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 367528
• Device Lot Number: 7135973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other