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

Catalog Number 20059E-0006

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that the bd alaris smartsite extension set experienced tubing that ballooned.The following information was provided by the initial reporter: the patient required ct with contrast.It was relayed to the radiology department that the patient had extension tubing insitu.When patient attended imaging the extension could not hold the volume of fluid and exploded.The extension was removed and the fluid continued via the bung.Pt escorted to ct.Contrast attempted with pivc extension unable to handle pressure and explosion of extension line -nil harm to pt.Bung applied with ct/radiology supply of bungs and female style connection (concaved) rather than flat with pivc patent and nil concerns.

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation: a 20059e-0006 product was not available for investigation; and the lot number of the affected product was not provided.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph identified that the tubing of the 20059e-0006 sample had burst during contrast injection.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and 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.Please note the 20059e-0006 set is validated to withstand pressures of up to 2 bar, if the product is subjected to pressures in excess of 2 bar it is possible for the reported leakage to occur.

Event Description

It was reported that the bd alaris smartsite extension set experienced tubing that ballooned.The following information was provided by the initial reporter: the patient required ct with contrast.It was relayed to the radiology department that the patient had extension tubing insitu.When patient attended imaging the extension could not hold the volume of fluid and exploded.The extension was removed and the fluid continued via the bung.Pt escorted to ct.Contrast attempted with pivc extension unable to handle pressure and explosion of extension line -nil harm to pt.Bung applied with ct/radiology supply of bungs and female style connection (concaved) rather than flat with pivc patent and nil concerns.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• Type of Device: 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: 14381121
• MDR Text Key: 291595150
• Report Number: 9616066-2022-00597
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20059E-0006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1