MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE UNKNOWN BD VACUTAINER® URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Catalog Number	364975
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, when using the unknown bd vacutainer® urine complete cup kit.The nurse accidently inserting their finger in the recessed sharps area.The following information was provided by the initial reporter.The customer stated: it was reported by the customer, that needlestick injuries, while using bd urine collection cups.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the unknown bd vacutainer® urine complete cup kit the nurse accidently inserting their finger in the recessed sharps area.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that needlestick injuries while using bd urine collection cups.
Additional Manufacturer Narrative
H.6 investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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.

• Brand Name: UNKNOWN BD VACUTAINER® URINE COMPLETE CUP KIT
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jo doyka ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18050333
• Report Number: 1920898-2023-00745
• Device Sequence Number: 8026353
• Product Code: JSM
• UDI-Device Identifier: 00382903649754
• UDI-Public: (01)00382903649754
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown