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

Catalog Number CS42522E-07

Device Problem Component Missing (2306)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd¿ gravity infusion set had no tubing clamp.The following information was provided by the initial reporter: "opsc preoperative care rn opened a bd gravity iv set and noticed there was not a roller clamp on it.Tubing was not primed or used.We reported such an event as you know back in april.Because our team did not provide an actual lot# (it appears that the listed the bar code# on that event as the lot#.), i can¿t tell if it¿s an issue with the lot number.And given that the first report was in april, i do not know if they are working from the same box.However, going forward, i¿ve confirmed the lot number on this event is the actual lot# to report.Customer response on (b)(6) 2023 , was there any medical intervention due to this incident? no.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-aug-2023.H6: investigation summary one sample was received for quality investigation.The customer complaint of clamp missing was verified by inspection.Evaluation of the sample submitted indicates that roller clamp was missing from the assembly.Further examination did not identify any other issues in the construction of the assembly.A device history record review for model cs42522e-07 lot number 22119265 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the missing clamp is due to the assembler distraction and not following the correct assembly procedure and not adding the roller clamp to the tubing before the tubing was combined with the other components.

Event Description

It was reported that the bd¿ gravity infusion set had no tubing clamp.The following information was provided by the initial reporter: "opsc preoperative care rn opened a bd gravity iv set and noticed there was not a roller clamp on it.Tubing was not primed or used.We reported such an event as you know back in april.Because our team did not provide an actual lot# (it appears that the listed the bar code# on that event as the lot#.), i can¿t tell if it¿s an issue with the lot number.And given that the first report was in april, i do not know if they are working from the same box.However, going forward, i¿ve confirmed the lot number on this event is the actual lot# to report.Customer response on (b)(6) 2023 was there any medical intervention due to this incident? no.".

• Brand Name: BD¿ GRAVITY INFUSION 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17546762
• MDR Text Key: 321223585
• Report Number: 9616066-2023-01739
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CS42522E-07
• Device Lot Number: 22119265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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