MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GEM NV BLD 15DP W/180 FLTR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10015414
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd gem nv bld 15dp w/180 fltr leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: when did the incident occur? (b)(6) 2022 at completion of blood transfusion, dry blood noted to be near the drip chamber.
Additional Manufacturer Narrative
Initial reporter facility name: hospital of the university of pennsylvania - cedar avenue (fka mercy catholic me).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd gem nv bld 15dp w/180 fltr leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: when did the incident occur? 8/13/2022 at completion of blood transfusion, dry blood noted to be near the drip chamber.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of tubing leaking below the pump chamber could not be verified due to the product not being returned for failure investigation.Device history record review for model 10015414 lot number 21086332 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.

• Brand Name: BD GEM NV BLD 15DP W/180 FLTR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15375996
• Report Number: 9616066-2022-01301
• Device Sequence Number: 20190957
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: 10885403233999
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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): 02/15/2023

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: 08/26/2024
• Device Catalogue Number: 10015414
• Device Lot Number: 21086332
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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