MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SECONDARY SET C61; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515302

Device Problem Material Deformation (2976)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd secondary set c61 the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: tubing was found damaged after opened from packaging.Tubing of secondary set was intact with the seal on the packaging.Hence, the tubing was damaged by the sealing process.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 1022262.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a photograph of the reported event has been provided.Our engineers noted that the tubing in the photograph had been sandwiched between the top and bottom webbing of the packaging.Based on this image they have determined that the root cause is most likely related to human error during the manual packaging process.To prevent future occurrences of this issue the appropriate personnel have been notified of the situation in order to raise awareness of similar non-conformances and increase the accuracy of remedial actions.

Event Description

It was reported while using bd secondary set c61 the tubing was damaged.There was no report of patient impact.The following information was provided by the initial reporter: tubing was found damaged after opened from packaging.Tubing of secondary set was intact with the seal on the packaging.Hence, the tubing was damaged by the sealing process.

• Brand Name: BD SECONDARY SET C61
• 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: 16250893
• MDR Text Key: 308571242
• Report Number: 9616066-2023-00087
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515302
• Device Lot Number: 1022262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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