MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367957

Device Problem Fungus in Device Environment (2316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".

Manufacturer Narrative

H6: investigation summary: bd had not received samples, but four (4) photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter (fm) was observed.The photos showed black and red dot-like fm inside the tube.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of fm was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of fm.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 09-mar-2022.H.6.Investigation: bd received thirty-four (34) samples and four (4) photos for investigation.The photos were reviewed and the indicated failure mode for foreign matter (fm) was observed.Black and red dot-like fm was observed inside the tube.The customer samples were visually examined and thirteen (13) of the samples were observed having the same fm on top of the gel.Additionally, one hundred (100) retention samples from bd inventory, were evaluated by visual examination and the issue of fm was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of fm.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube there was a presence of mold.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: there was a "sterility failure during the manufacturing of dry tubes of lot 1253915.Six tubes showing the phenomenon have been sent from the emergency department to the laboratory.These photos of 4 tubes show elements resembling molds.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13445041
• MDR Text Key: 286244720
• Report Number: 9617032-2022-00058
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: 50382903679572
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: 1253915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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