MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E (EDTA) 7.2MG TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368861

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® k2e (edta) 7.2mg tubes do not fill completely.

Event Description

It was reported that 50 bd vacutainer® k2e (edta) 7.2mg tubes do not fill completely.

Manufacturer Narrative

The following field has been updated due to corrected information: describe event or problem: it was reported that 50 bd vacutainer® k2e (edta) 7.2mg tubes do not fill completely.Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for underfill with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the issue relating to underfill 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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for underfill with the incident lot was observed.Additionally, evaluation/testing of the retain samples was conducted and underfill 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.Root cause description: 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.Rationale: 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® K2E (EDTA) 7.2MG TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 8207043
• MDR Text Key: 131763351
• Report Number: 9617032-2018-03245
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903688611
• UDI-Public: 50382903688611
• 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: 02/22/2019

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: 06/30/2019
• Device Catalogue Number: 368861
• Device Lot Number: 8040575
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other