MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number 990687

Device Problems Component or Accessory Incompatibility (2897); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

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

Event Date 08/03/2023

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 syringe pump alarm went off while using the bd plastipak¿ luer-lok¿ syringe due to the plunger being stuck while administering propofol.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from spanish: "i hereby inform you of the technical claim reported with the product in question and the description of some of the reports that have been received: propofol medication is prepared, to be administered as an infusion by tci pump to the patient.Which when activating start of infusion goes to occlusion alarm, venous access is verified, patent, syringe is withdrawn, plunger plugged, syringe hard to administer.Medications are exchanged for a 50cc syringe and the infusion is started without problem.The medicine is passing, the plunger is getting stuck, it fills with air and starts beeping in an interview with operating room personnel, they state that these events have come being repetitive, appearing almost daily during the last months, however, given the recurrence and need to resolve the events, the syringes are not available physically, since they are discarded during surgical procedures.Is done traceability of the consumption of syringes during the month of july and august, giving a consumption of 1000 syringes in the period 07/01/2023 ¿ 08/16/2023.

Manufacturer Narrative

Videos received by our quality team for investigation.Video provided shows the syringe installed in the pump giving an alarm.A device history review was performed for the reported lot 2202300, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no defects or issues observed.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.It is important the 20ml plastipak is enabled in the pump.

Event Description

Propofol medication is prepared, to be administered as an infusion by tci pump to the patient.Which when activating start of infusion goes to occlusion alarm, venous access is verified, patent, syringe is withdrawn, plunger plugged, syringe hard to administer medications are exchanged for a 50cc syringe and the infusion is started without problem.The medicine is passing, the plunger is getting stuck, it fills with air and starts beeping.In an interview with operating room personnel, they state that these events have come being repetitive, appearing almost daily during the last months, however, given the recurrence and need to resolve the events, the syringes are not available physically, since they are discarded during surgical procedures.Is done traceability of the consumption of syringes during the month of july and august, giving a consumption of 1000 syringes in the period (b)(6) 2023.

Manufacturer Narrative

Additional information received by customer on 12/05/2023, translated from spanish to english: do all observed incidents belong to the same catalog and lot? if not, what are the affected lots and quantities respectively? yes, all incidents correspond to the same reference, and to the same batch.How many products presented the reported deviation? an estimated 80 - 100 syringes are made.The operating room staff was reiterative in mentioning that the events occurred almost every day.Within the opportunity in patients' health care, they looked for alternatives to carry out the procedures, which is why they did not make quality reports for each event presented.The problem presented with the product was discussed verbally with the ward coordinator nurse, who was in charge of notifying the events that were identified.Has there been any harm to the patient/healthcare professional? (detail) there was no harm to any patient or health personnel.However, there was a delay in the development of the procedures carried out.Was there a need for medical and/or surgical intervention due to what occurred (imaging examinations, surgery, medication administration, etc.)? (detail) there was no need for any medical or surgical intervention.

Event Description

Additional information received by customer on 12/05/2023, translated from spanish to english: do all observed incidents belong to the same catalog and lot? if not, what are the affected lots and quantities respectively? yes, all incidents correspond to the same reference, and to the same batch.How many products presented the reported deviation? an estimated 80 - 100 syringes are made.The operating room staff was reiterative in mentioning that the events occurred almost every day.Within the opportunity in patients' health care, they looked for alternatives to carry out the procedures, which is why they did not make quality reports for each event presented.The problem presented with the product was discussed verbally with the ward coordinator nurse, who was in charge of notifying the events that were identified.Has there been any harm to the patient/healthcare professional? (detail) there was no harm to any patient or health personnel.However, there was a delay in the development of the procedures carried out.Was there a need for medical and/or surgical intervention due to what occurred (imaging examinations, surgery, medication administration, etc.)? (detail) there was no need for any medical or surgical intervention.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17691130
• MDR Text Key: 322745621
• Report Number: 3003916417-2023-00266
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990687
• Device Lot Number: 2202300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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