MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD LUER-LOK¿ 1-ML SYRINGE; PISTON SYRINGE

Catalog Number 302485

Device Problem Material Separation (1562)

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

Event Date 05/12/2023

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 the bd luer-lok¿ 1-ml syringe plunger came out of the syringe sheath.The following information was provided by the initial reporter: the syringe plunger comes out of the syringe sheath.Additional information received on 01.Jun.2023: was the reported incident noticed before, during or after use? a: in a technical review for a tender.Has there been any harm to the patient / healthcare professional? (detail) a: no was there a need for medical and/or surgical intervention due to what happened (imaging tests, surgery, medication administration, etc.)? (detail) a: no.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 20-jun-2023.H.6.Investigation summary: eighty five samples and video received by our quality team for investigation.Through visual evaluation, no defects or damage observed on the syringes.Silicone content tests were conducted for each sample, all samples were evaluated and found to be within required specifications.The plunger is removed from the samples to evaluate the diameter of the retaining ring.When carrying out this activity, the slight resistance that occurs between the stopper and the diameter of the retaining ring is noted to separate them, therefore the results are within specification.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.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd luer-lok¿ 1-ml syringe plunger came out of the syringe sheath.The following information was provided by the initial reporter: the syringe plunger comes out of the syringe sheath.Additional information received on 01.Jun.2023: was the reported incident noticed before, during or after use? a: in a technical review for a tender.Has there been any harm to the patient / healthcare professional? (detail) a: no was there a need for medical and/or surgical intervention due to what happened (imaging tests, surgery, medication administration, etc.)? (detail).A: no.

• Brand Name: BD LUER-LOK¿ 1-ML 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 DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17080394
• MDR Text Key: 316726768
• Report Number: 9614033-2023-00044
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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: Other
• Device Catalogue Number: 302485
• Device Lot Number: 1286293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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