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

Catalog Number 990687

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe had difficult plunger movement while administering medication.The following information was provided by the initial reporter, translated from spanish: "when inspecting the syringes we identified that the new packaging changes to a purple color and the reference code is the same (ref: (b)(4), additionally we can perceive a slight difference in the resistance required to actuate the syringe, which causes the perfusor to require more pressure on the plunger to administer the medication, and this triggers the equipment to present the system alarm.Important: on the packaging of the device, it is not possible to identify the health registration number, nor any other information regarding its importation into mexico.Deficiencies in the operation: difference in the description of the device, with respect to the previous code.Differences between the countries of manufacture no information on the expiration date lack of sanitary registration, at least described in the packaging of the device.The lot with which we present the situation is: 2202309 fab2022-08.".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Photo received by our quality team for investigation.Through visual inspection, product packaging is observed, no defects or issues observed.Unable to confirm incident based on images, physical sample is required to further analyze.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Retention samples from the same lot were evaluated, no defects or issues observed.Based on the available information we are not able to determine a root cause at this time.Regarding the label content issue, catalog 990687, the registration number is detailed on the back label of the secondary packaging.

Event Description

When inspecting the syringes we identified that the new packaging changes to a purple color and the reference code is the same (ref: (b)(4)), additionally we can perceive a slight difference in the resistance required to actuate the syringe, which causes the perfusor to require more pressure on the plunger to administer the medication, and this triggers the equipment to present the system alarm.Important: on the packaging of the device, it is not possible to identify the health registration number, nor any other information regarding its importation into mexico.Deficiencies in the operation: difference in the description of the device, with respect to the previous code.Differences between the countries of manufacture no information on the expiration date lack of sanitary registration, at least described in the packaging of the device, so i also request support to validate the documentation, and that we get it.The lot with which we present the situation is: 2202309 fab2022-08.

• 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: 17467411
• MDR Text Key: 321239877
• Report Number: 3003916417-2023-00205
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990687
• Device Lot Number: 2202309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• 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