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

Catalog Number	367671
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7157752; medical device expiration date: 2018-12-31; device manufacture date: 2017-06-06; medical device lot #: 7305594; medical device expiration date: 2019-05-31; device manufacture date: 2017-11-01; medical device lot #: 7340869; medical device expiration date: 2019-06-30; device manufacture date: 2017-12-06.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd vacutainer® sodium heparin (nh) blood collection tubes were underfilling.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, 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.Although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).Capa (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.
Event or Problem Description
It was reported that the bd vacutainer sodium heparinn (nh) blood collection tubes were underfilling.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7890190
• Report Number: 1917413-2018-03481
• Device Sequence Number: 169211
• Product Code: JKA
• UDI-Device Identifier: 50382903676717
• UDI-Public: 50382903676717
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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
• Operator of Device: Other
• Device Catalogue Number: 367671
• Device Lot Number: SEE SECTION H.10.
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other