MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD VP SERIES LIGHT RESISTANT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 70643

Device Problems Disconnection (1171); Material Separation (1562)

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

Event Date 08/08/2023

Event Type  malfunction  

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

It was reported that bd vp series light resistant set separated.The following information was received by the initial reporter with the verbatim: line disconnection at blue filter response received please confirm when the reported defect was identified, i.E., during priming, or during an infusion = during the infusion.If during an infusion, please confirm how long the infusion had been running = approx 13hrs.Please provide further details regarding the sequence of events prior to the separation/disconnection occurring? = patient had woken up and was sat with nurse.Another nurse then noticed the extension line from the blue filter of the pn circuit had become loose.Attempted to tighten the connection but the line and the filter then separated completely.Please confirm where on the set the separation/disconnection occurred? please note that the 70643 does not have a blue filter; therefore, please provide a photograph or diagram to clarify this, if possible =the filters are added to the circuit separately.The disconnection was between the extension line an the blue filter.Picture of how the circuit should look attached.Please note this is not a picture of this actual set.Please confirm if any physical damage or deformity was observed at the point of separation/disconnection? none noted.Please confirm if any leakage occurred as a result of the separation/disconnection? no leakage as was identified by nursing staff.If yes, please confirm what fluid was being administered at the time of the event?.

Manufacturer Narrative

Investigation results: one 70643 sample was received for investigation of pr 9129875, in which the customer has stated: "line disconnection at blue filter." the 70643 was received connected to a smartsite component on a short 2-way extension set, which was connected to a standalone filter, which inturn connected to an unknown long extension set.Residual fluid was received throughout all of the samples.No packaging was received with any of the samples, and the customer has not provided a lot number for the 70643 product.Examination of the returned samples found that the connection between the 70643 and smartsite was secure, with no fluid leakage or air ingress occurring under gravity flow conditions, or when additional pressure was applied via syringe.The female luers of the other two received products were also similarly tested when connected to the 70643; again, no fluid leakage or air ingress was observed.The details of this feedback were forwarded to the manufacturing site for investigation; however, in this instance a lot number was not provided and therefore it was not possible to perform a review of the production documentation for the 70643 product.The root cause of the customer¿s experience could not be determined in this instance as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.In this instance it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the 70643 product in the past 12 months.

Event Description

No additional information.

• Brand Name: BD VP SERIES LIGHT RESISTANT 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: 18166435
• MDR Text Key: 328643164
• Report Number: 9616066-2023-02212
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203019713
• UDI-Public: (01)37613203019713
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 70643
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1