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

Catalog Number	10037031
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter email- (b)(6).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite gravity burette set was occluded.The following information was received by the initial reporter with the following verbatim: stricture/weakness in plastic lumen occluding flow just below the drip chamber.Pediatric patient drugs delayed at induction causing risk to airway patency.Disposed of due to contamination.Photo taken of fault before disposal.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a (b)(6) sample was not available for investigation; however the customer indicates that the tubing below the drip chamber of the burette was 'collapsed'.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph confirmed a deformation below the drip chamber, however the nature of the deformation was not conclusive.The details of this feedback were forwarded to the manufacturing site for investigation; however the lot information provided by the customer did not match the reported product code, therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the 10037031 product.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BURETTE 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: 18341409
• Report Number: 9616066-2023-02408
• Device Sequence Number: 15152828
• Product Code: FPA
• UDI-Device Identifier: 07613203010399
• UDI-Public: (01)07613203010399
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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: Health Professional
• Device Catalogue Number: 10037031
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown