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

Model Number 367986

Device Problem Fungus in Device Environment (2316)

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

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there was possibly a fungus inside the gel with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter, translated from spanish to english: it was detected in a 367986 tube a particle inside the gel, possibly a fungus.

Manufacturer Narrative

H.6.Investigation: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, evaluation of the customer samples was performed and foreign matter was 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 non-conformances during manufacturing of the product.

Event Description

It was reported that there was possibly a fungus inside the gel with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter, translated from spanish to english: it was detected in a 367986 tube a particle inside the gel, possibly a fungus.

• 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: 9716940
• MDR Text Key: 186304524
• Report Number: 1024879-2020-00104
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 9277915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other