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

Model Number 366703

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: bdj received actual customer samples to be evaluated and seven (7) photos from the customer facility.The photos showed the customer¿s failure mode of: ¿embedded fm (tube)¿ and ¿fm¿.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.

Event Description

It was reported that foreign matter "black dots" were discovered in tubes prior to use with 21 bd vacutainer® no additive (z) tubes.The following information was provided by the initial reporter, translated from (b)(6) to english: black spot was found in tubes.

• 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: 10528916
• MDR Text Key: 209595038
• Report Number: 1917413-2020-00809
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 366703
• Device Catalogue Number: 366703
• Device Lot Number: 9280860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2019
• 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