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

Catalog Number 367968

Device Problems Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

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 that foreign matter was found before use with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter, "fm in separator x6.Deformed tube x3.Defective marking x39.Dirty shield x1.Black spots x2.Dirty tube x22.Gel airbubbles x86.Air bubbles in tube x1." 160 occurrences were reported.

Event Description

It was reported that foreign matter was found before use with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter, "fm in separator x6, deformed tube x3, defective marking x39, dirty shield x1, black spots x2, dirty tube x22, gel air bubbles x86, air bubbles in tube x1".160 occurrences were reported.

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 manufacturing records was completed for the incident lot and no issues were identified.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9071823
• MDR Text Key: 166975275
• Report Number: 1024879-2019-01648
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 10/17/2019

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: 04/30/2020
• Device Catalogue Number: 367968
• Device Lot Number: 9123770
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other