MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINALYSIS CUP KIT; SYSTEM, TRANSPORT, AEROBIC

Catalog Number 364946

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® urinalysis cup kit, the device experienced no label or missing label information ( all packaging level).The following information was provided by the initial reporter.The customer stated: it was reported that customer reports incidents where "extraction device for the urine, sicker would get pulled off by patient or just fall off leading to needle being exposed.".

Manufacturer Narrative

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.

Manufacturer Narrative

Investigation summary: no samples or photos were returned by the customer in support of this complaint.Lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.H3 other text : see h10.

Event Description

It was reported when using the bd vacutainer® urinalysis cup kit, the device experienced no label or missing label information ( all packaging level).The following information was provided by the initial reporter.The customer stated: it was reported that customer reports incidents where "extraction device for the urine, sicker would get pulled off by patient or just fall off leading to needle being exposed.".

• Brand Name: BD VACUTAINER® URINALYSIS CUP KIT
• Type of Device: SYSTEM, TRANSPORT, AEROBIC
• 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: 14349907
• MDR Text Key: 291360554
• Report Number: 1917413-2022-00253
• Device Sequence Number: 1
• Product Code: JTW
• UDI-Device Identifier: 00382903649464
• UDI-Public: 00382903649464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364946
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• 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