MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINALYSIS URINE TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364979
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was cracked tube.This event occurred 20 times.The following information was provided by the initial reporter.The customer stated: "the tubes are cracked.".
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was cracked tube.This event occurred 20 times.The following information was provided by the initial reporter.The customer stated: "the tubes are cracked.".
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for damage / scratch on product to the outside of the tube was observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of damage was not observed as no issues were identified.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 of damage / scratch on product based on the provided photo.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD VACUTAINER URINALYSIS URINE TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12533166
• Report Number: 1917413-2021-00847
• Device Sequence Number: 1271467
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 364979
• Device Catalogue Number: 364979
• Device Lot Number: 1040884
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1