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

Catalog Number 990687

Device Problem Material Separation (1562)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported that the stopper separated from the plunger while using the bd plastipak¿ luer-lok¿ syringe, leading to leakage.The following information was provided by the initial reporter, translated from portuguese to english: the pharmacist observed that the syringe plunger came off the retention stopper, leaking the aspirated liquid, causing its loss.

Manufacturer Narrative

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 stopper separated from the plunger while using the bd plastipak¿ luer-lok¿ syringe, leading to leakage.The following information was provided by the initial reporter, translated from portuguese to english: the pharmacist observed that the syringe plunger came off the retention stopper, leaking the aspirated liquid, causing its loss.

Manufacturer Narrative

H.6 investigation summary: photos received for investigation.Upon visual inspection, the defect/damage of separation of the stopper on the plunger was observed due to deformation in the stopper on the plunger.Possible root cause is associated with the stopper assembly process.As a corrective action, materials were removed from the rod feeders, segregation was performed, and the cavities identified in the mold were closed.Improvements in guides and rails to reduce losses was carried out to improve the efficiency of the equipment together with the proper rejection of non-conforming materials.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.

Manufacturer Narrative

H.6 investigation summary: photos received for investigation.Upon visual inspection, the defect/damage of separation of the stopper on the plunger was observed due to deformation in the stopper on the plunger.Possible root cause is associated with the stopper assembly process.As a corrective action, materials were removed from the rod feeders, segregation was performed, and the cavities identified in the mold were closed.Improvements in guides and rails to reduce losses was carried out to improve the efficiency of the equipment together with the proper rejection of non-conforming materials.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.H3 other text : see h10.

Event Description

It was reported that the stopper separated from the plunger while using the bd plastipak¿ luer-lok¿ syringe, leading to leakage.The following information was provided by the initial reporter, translated from portuguese to english: the pharmacist observed that the syringe plunger came off the retention stopper, leaking the aspirated liquid, causing its loss.

• 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
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14548701
• MDR Text Key: 293558901
• Report Number: 3003916417-2022-00076
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

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: 990687
• Device Lot Number: 1323993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/24/2022; 09/01/2022
• Supplement Dates FDA Received: 07/22/2022; 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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