MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD TUBE URIN PLC 16X100 10.0 UA YEL; AEROBIC TRANSPORT SYSTEM

Catalog Number	364979
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd tube urin plc 16x100 10.0 ua yel, the device experienced foreign matter within the fluid pathway.The following information was provided by the initial reporter.The customer stated: it was reported that the product was dirty.There was 1cs of part # 364979 that was rejected from po # bdi2111-23.The case came in open and product inside is dirty.
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.
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 tube urin plc 16x100 10.0 ua yel, the device experienced foreign matter within the fluid pathway.The following information was provided by the initial reporter.The customer stated: it was reported that the product was dirty.There was 1cs of part # 364979 that was rejected from po # (b)(4).The case came in open and product inside is dirty.
Additional Manufacturer Narrative
After further investigation the mdr 4207889, mfr reporting #: 1917413-2022-00004 was deemed not reportable and should not have been filed.This complaint is not mdr reportable.Not a product complaint per dchu.
Event or Problem Description
It was reported when using the bd tube urin plc 16x100 10.0 ua yel, the device experienced foreign matter within the fluid pathway.The following information was provided by the initial reporter.The customer stated: it was reported that the product was dirty.There was 1cs of part # 364979 that was rejected from po # (b)(4).The case came in open and product inside is dirty.

• Brand Name: BD TUBE URIN PLC 16X100 10.0 UA YEL
• Common Device Name: AEROBIC TRANSPORT SYSTEM
• 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: 13309285
• Report Number: 1917413-2022-00004
• Device Sequence Number: 3208122
• Product Code: JTW
• UDI-Device Identifier: 00382903649792
• UDI-Public: 00382903649792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790366
• 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): 01/31/2022

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: 09/30/2023
• Device Catalogue Number: 364979
• Device Lot Number: 1259198
• 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: 12/31/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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
• Patient Sex: Unknown