MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE; TRANSPORT CULTURE MEDIUM

Catalog Number 364955

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the rack bd vacutainer z365000 & 364955 there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "glass contaminated after the use.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 4 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter was observed.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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode foreign matter.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the rack bd vacutainer z365000 & 364955 there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "glass contaminated after the use.".

Event Description

It was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "glass contaminated after the use.".

Manufacturer Narrative

The following fields have been updated: site legal name: becton dickinson & co - broken bow, ne 68822.B5.Describe event or problem: it was reported when using the bd vacutainer® boric acid sodium borate/formate c&s urine tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "glass contaminated after the use." d1: medical device brand name: bd vacutainer® boric acid sodium borate/formate c&s urine tube.D2a: common device name: transport culture medium.D2b: medical device type: jsm.D3: medical device manufacturer: becton, dickinson & co.(broken bow).D4: catalog: 364955.D4: lot# 2125687.D4: exp date: 30-nov-2023.D4:udi: (b)(4).G1: manufacturing location: becton, dickinson & co.(broken bow).

• Brand Name: BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Type of Device: TRANSPORT CULTURE MEDIUM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16444242
• MDR Text Key: 310358533
• Report Number: 2243072-2023-00264
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: MB
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 364955
• Device Lot Number: 2125687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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