MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

Catalog Number 367378

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8120558, expiration date: 2019-10-31, manufacture date: 2018-04-30.Medical device lot #: 8050690, expiration date: 2019-08-31, manufacture date: 2018-02-19.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 bd vacutainer® lh pst¿ ii plus blood collection tubes experienced clotting.It was stated "after removal blood coagulates in the plasma tube, after centrifugation plasma is gel-like and not liquid." no report of serious injury or medical intervention.

Event Description

It was reported that bd vacutainer lh pst ii plus blood collection tubes experienced clotting.It was stated "after removal blood coagulates in the plasma tube, after centrifugation plasma is gel-like and not liquid." no report of serious injury or medical intervention.

Manufacturer Narrative

Bd received samples from the customer facility for investigation.Evaluation of the customer samples was conducted and a lack of heparin additive was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to missing additive was not 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.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Based on the evaluation of the customer samples, a lack of heparin additive was observed.Additionally, evaluation of the retain samples was conducted and missing additive was not observed.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.A capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.(b)(4).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 on-going and further improvements will be made as the potential root cause(s) are identified.

• Brand Name: BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7656234
• MDR Text Key: 113184244
• Report Number: 9617032-2018-00346
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K022130
• 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: 10/09/2018

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: Other
• Device Catalogue Number: 367378
• Device Lot Number: SEE H.10.
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other