MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367986

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Bd has initiated further investigation relating to this issue through a capa.The investigation is still ongoing and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: as no samples or photos were received for evaluation, the customers' indicated failure mode was not observed by bd.However, further investigation has been initiated through a capa.The investigation is still ongoing and improvements will be made as the potential causes are identified.Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently ongoing and further improvements will be made as the potential root cause(s) are identified.

Event Description

It was reported that the gel in the bd vacutainer® sst¿ blood collection tubes "failed to separate completely", with part of the gel forming the barrier, and some of the gel found in the red blood cells.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the gel in the bd vacutainer® sst¿ blood collection tubes "failed to separate completely", with part of the gel forming the barrier, and some of the gel found in the red blood cells.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7665313
• MDR Text Key: 113570154
• Report Number: 1024879-2018-00322
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• 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: 08/21/2018

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: No Information
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 367986
• Device Lot Number: 8102724
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other