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

Catalog Number 367812

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/30/2019

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 an unspecified number of bd vacutainer® serum blood collection tubes experienced molding defects with sharp protrusions which were noted during use.The following information was provided by the initial reporter: during use, the customer found 1ea tube bottom was damaged, causing bleeding.

Manufacturer Narrative

Bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for broken bottom on tube with the incident lot was observed as all product specifications were met.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 an unspecified number of bd vacutainer® serum blood collection tubes experienced molding defects with sharp protrusions which were noted during use.The following information was provided by the initial reporter: during use, the customer found 1ea.Tube bottom was damaged, causing bleeding.

• Brand Name: BD VACUTAINER® SERUM 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: 8894936
• MDR Text Key: 156950428
• Report Number: 1024879-2019-01424
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678124
• UDI-Public: 50382903678124
• 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: 09/17/2019

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: 367812
• Device Lot Number: 9010913
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other