MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	37262E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name- (b)(6) hospital.H3.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 bd alaris smartsite extension set was damaged and leaking.The following information was received by the initial reporter with the verbatim: extension tubing found to be cracked where extension tubing and primary iv tubing connect.As a result, blood backflowed into tubing and leaked out of crack.
Additional Manufacturer Narrative
It was reported by customer that extension tubing found to be cracked where extension tubing and primary iv tubing connect.One sample of extension set material number 37262e, lot number 23049079, connected to an unidentified primary infusion set.Visual examination of the extension set showed that the female luer connector had a large crack (see photo).The extension set was connected to the primary set and a simulated infusion was conducted to determine if the cracked connector allowed for leakage.Leakage was confirm when the tubing was primed.The investigation was forwarded to the manufacturing facility and it was determined that the possible root causes were due to over tightening of the luer during connection or possibly using an antiseptic cleaner on the luer before connect it.Antiseptic cleaners can cause the connector material to be brittle and crack easily when connected.The bd clinical team has been contacted and will follow-up with the customer in cause further information is needed in the proper method of connecting the luers.Additionally, the connector supplier has been made aware of the failure to monitor for further issues concerning this component.A device history record review for model 37262e lot number 23049079 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.Material #: 37262e.Batch #: 23049079.It was reported by customer that extension tubing found to be cracked where extension tubing and primary iv tubing connect.As a result, blood backflowed into tubing and leaked out of crack.Verbatim: rcc received a complaint via email.Email(s) attached.Extension tubing found to be cracked where extension tubing and primary iv tubing connect.As a result, blood backflowed into tubing and leaked out of crack.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18253662
• Report Number: 9616066-2023-02315
• Device Sequence Number: 6203614
• Product Code: FPA
• UDI-Device Identifier: 50885403235274
• UDI-Public: (01)50885403235274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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: 04/05/2026
• Device Catalogue Number: 37262E
• Device Lot Number: 23049079
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 12/03/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown