MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® C&S TRANSFER STRAW KIT; TRANSPORT CULTURE MEDIUM

Model Number 364953

Device Problems Component Missing (2306); Physical Resistance/Sticking (4012)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for missing holder 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 missing holder.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® c&s transfer straw kit the needle was missing the safety cover, thus having a clean needle stick injury with health care provider.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: hazard, injury or erroneous results details how did the needle stick incident occur: tech was stuck by needle.Was it a clean needle or a used needle: clean.Was the proper technique used: tech was wearing proper ppe at the time and was only reaching back into the packaging to get the grey top tube.Was medical intervention required or necessary: no.Customer states needle was missing the safety hub covering, causing a needle stick.

• Brand Name: BD VACUTAINER® C&S TRANSFER STRAW KIT
• 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 ; 8015296192
• MDR Report Key: 16030219
• MDR Text Key: 306840940
• Report Number: 1917413-2022-00805
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024240
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 364953
• Device Catalogue Number: 364953
• Device Lot Number: 2251934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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