MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368587
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	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® sodium fluoride 10 mg potassium oxalate 8 mg (fx) tubes had low draw.This occurred on 5 occasions during use.The following information was provided by the initial reporter: material no.: 368587.Batch/lot: 8345628.It was reported that "when they slid the tubes onto the needle holders it acted like they were not in a good vein.Group was having issues with some of the t03 tubes.When they slid the tubes onto the needle holders it acted like they were not in a good vein.The problem with that is they had already drawn blood tubes before and after they tried with the gray tubes and they didn¿t have to move the needle at all.
Event or Problem Description
It was reported that bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) tubes had low draw.This occurred on 5 occasions during use.The following information was provided by the initial reporter: material no.: 368587.Batch/lot: 8345628.It was reported that "when they slid the tubes onto the needle holders it acted like they were not in a good vein.Group was having issues with some of the t03 tubes.When they slid the tubes onto the needle holders it acted like they were not in a good vein.The problem with that is they had already drawn blood tubes before and after they tried with the gray tubes and they didn¿t have to move the needle at all.".
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for underfill with the incident lot 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 (b)(4).The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE 10MG POTASSIUM OXALATE 8 MG (FX) TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8926868
• Report Number: 1917413-2019-01966
• Device Sequence Number: 13513550
• Product Code: JKA
• UDI-Device Identifier: 50382903685870
• UDI-Public: 50382903685870
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• 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): 09/10/2019

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
• Operator of Device: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 368587
• Device Lot Number: 8345628
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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