MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GRAV 100DP CV 2SS 4W STD STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Model Number	42503E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd grav 100dp cv 2ss 4w std stopcock experienced the tubing breaking.The following information was provided by the initial reporter: tubing keeps breaking.
Additional Manufacturer Narrative
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 that the bd grav 100dp cv 2ss 4w std stopcock experienced the tubing breaking.The following information was provided by the initial reporter: tubing keeps breaking.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of tubing breaking was received from the customer.Two samples were returned for investigation.Through visual inspection the customer complaint was confirmed.The two samples had separated at the drip chamber.The sample with the known lot ( 21109322) looked damaged on the drip chamber connection site.There also looked to be a ring of solvent on the tubing.The unknown lot sample did not have the same damage on the drip chamber and the tubing looked to have a ring of solvent.A device history record review for model 42503e lot number 21109322 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 21oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect.The root cause for this separation is a lack of solvent added to the drip chamber and tubing connection.Due to an increase in incidents of this failure mode, a trend for this separation issue has been identified for this product line, a capa (corrective action preventative action) 3974230 has been initiated, and a team has been assembled in order to investigate the issue.

• Brand Name: BD GRAV 100DP CV 2SS 4W STD STOPCOCK
• 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: 15198820
• Report Number: 9616066-2022-01122
• Device Sequence Number: 2150265
• Product Code: FPA
• UDI-Device Identifier: 50885403235397
• UDI-Public: 50885403235397
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 08/18/2022

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: 10/21/2024
• Device Model Number: 42503E
• Device Catalogue Number: 42503E
• Device Lot Number: 21109322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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