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

Catalog Number 2420-0500

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set was damaged.The following information was received by the initial reporter with the verbatim: nurse was priming iv tubing with fluids to be used on patient and tubing split.Additional info from customer: (04-sep-2023) in answer to your questions: -no serious adverse event occurred -i previously sent pics with the lot numbers that were in stock on the unit where this occurred -date of occurrent 8/10/23 -tubing was given to sheila rogers in materials here at srh to send back to bd.I no longer have it.Hope this helps.I have no further information.Additional info from customer: 07-sep-2023 i cannot get a picture to print, still having issues within our system, but the following lot numbers were in the supply closet that this tubing was pulled from (10)23063279 (10)23065414 (10)23063288 or may be 86 additional info from customer: 08-sep-2023 we do not know which lot the defective tubing came from because the packaging was thrown away.The 3 numbers provided are what they had in their supply closet.That is the only information that was given to me.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional information was provided.Material#:(b)(4) batch#:23063279, 23065414, 23063288 it was reported by customer that nurse was priming iv tubing with fluids to be used on patient and tubing split.Verbatim: nurse was priming iv tubing with fluids to be used on patient and tubing split.Additional info from customer: (04-sep-2023) in answer to your questions: -no serious adverse event occurred -i previously sent pics with the lot numbers that were in stock on the unit where this occurred -date of occurrent (b)(6) 2023 -tubing was given to (b)(6) in materials here at srh to send back to bd.I no longer have it.Hope this helps.I have no further information.Additional info from customer: 07-sep-2023 i cannot get a picture to print, still having issues within our system, but the following lot numbers were in the supply closet that this tubing was pulled from.(10)23063279 (10)23065414 (10)23063288 or may be 86 additional info from customer: 08-sep-2023 we do not know which lot the defective tubing came from because the packaging was thrown away.The 3 numbers provided are what they had in their supply closet.That is the only information that was given to me.

Manufacturer Narrative

It was reported by customer that nurse was priming iv tubing with fluids to be used on patient and tubing split.One sample of material (b)(4), was submitted for quality investigation.Evaluation of the sample submitted, shows that tubing is cut.Examination of the cut under magnification, indicates that the cut did not have any indication of stretching or ballooning that may have caused the tube to separate.The cuts have distinct sharp edges, which are typical of a cut caused by a sharp edged tool or surface.The customer complaint of tubing defect/damaged was verified by investigation.Further investigation was conducted at the manufacturing locations to determine the root cause of the failure.The manufacturing processes were investigated and reviewed for any potential possibilities that the tubing could have been cut in the same manner as the returned sample.There were no definitive causes identified during the manufacturing process.The potential root cause for the issue is that personnel in training may have incorrectly handled the tubing that was to be used in the assemblies, causing cuts in the tubing.Manufacturing will continue to monitor its processes for any similar incidences.The lot number of the submitted sample is unknown.The device history review was conducted based on the possible lot numbers found by tracing the smartsite id numbers on the sample received.A device history record review for model 2420-0500 lot number 23065381 was performed.The search showed that a total of 86,403 units in 1 lot number was built on 19jun2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 23085228 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08aug2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 23085101 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02aug2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 23085119 was performed.The search showed that a total of (b)(4)units in 1 lot number was built on 02aug2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see narrative below.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18210192
• MDR Text Key: 329025961
• Report Number: 9616066-2023-02265
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: (01)37613203012448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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
• Device Operator: Other
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1