MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT & STORAGE CONTAINER.

Catalog Number 366703

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

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

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device evaluated by mfr: 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.Device manufacture date: unknown.

Event Description

Material no: 366703, batch no: unknown.It was reported that during use of the bd vacutainer® no additive (z) tubes some of the nurses commented that the tubes do not have enough vacuum to achieve the required 2 ml of waste.The following information was provided by the initial reporter: some of their nurses have commented that the tubes do not have enough vacuum to achieve the required 2 ml of waste.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

Material no: 366703, batch no: unknown.It was reported that during use of the bd vacutainer® no additive (z) tubes some of the nurses commented that the tubes do not have enough vacuum to achieve the required 2 ml of waste.The following information was provided by the initial reporter: some of their nurses have commented that the tubes do not have enough vacuum to achieve the required 2 ml of waste.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT & STORAGE CONTAINER.
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8839310
• MDR Text Key: 154143348
• Report Number: 1917413-2019-01827
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 366703
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other