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

Catalog Number 366703

Device Problem Leak/Splash (1354)

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

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to stopper pop off as all samples met specifications.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- conformance during manufacturing of the product.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for stopper pop off with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.

Event Description

It was reported that cap pop off occurred during use with a bd vacutainer® no additive (z) tubes.The following information was provided by the initial reporter, "it was reported that the caps are popping off.7 of 14: date of event: (b)(6) 2019.I am reaching out to you to bring an ongoing issue to your attention.We have been consistently having issues with caps (recapped) staying on one of our vacutainer tubes (clear top used for urine chemistries).I am not sure if this issue has been discussed with you already.These blue caps that are used for recapping purposes come from our automation line vendor and usually work fine with all other vacutainers that come from bd but this particular one.At this point, we really need to see what our alternatives are.The caps popping everywhere from these urine chemistry tubes are causing downtimes for us and extra manual handling for our teams." 7 of 14 complaints.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9377880
• MDR Text Key: 181360498
• Report Number: 1917413-2019-02443
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2019

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: 10/31/2020
• Device Catalogue Number: 366703
• Device Lot Number: 9095730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other