MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 10ML S/SU

Catalog Number 990172

Device Problem Defective Component (2292)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd syringe plastipak 10ml s/su stopper was defective/damaged.The following information was provided by the initial reporter translated from portuguese to english: "crooked syringe" "not 361/23 - 10ml hypodermic disposable syringe with luer lock bible, material received through invoice 765536, issued on 12/19/2023.I have received 1 sample of the notified material to send for analysis." however, based on the image provided, the issue appears to be related to a crooked stopper.Additional information received on 01/09/2024: was the reported incident noticed before, during or after use on the patient? a: before use was there any harm to the patient/healthcare professional? (detail) a: there was no harm was there a need for medical and/or surgical intervention because of what happened (imaging tests, surgery, administration of medication, etc)? (detail) a: there was no need.

Event Description

No additional information.

Manufacturer Narrative

Photo received by our quality team for investigation.Additionally, physical sample received.Through visual inspection, it was observed that the stopper was incorrectly assembled to the plunger, distorted against the barrel wall.A device history was performed and found maintenance record related to the reported issue during production of batch 3324321.This issue was determined to have occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.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.

Manufacturer Narrative

Photo received by our quality team for investigation.Through visual inspection, it was observed that the stopper was incorrectly assembled to the plunger, distorted against the barrel wall.A device history was performed and found maintenance record related to the reported issue during production of batch 3324321.This issue was determined to have occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.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.

Event Description

No additional information.

• Brand Name: BD SYRINGE PLASTIPAK 10ML S/SU
• Type of Device: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18546939
• MDR Text Key: 333540556
• Report Number: 3003916417-2024-00004
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000378
• UDI-Public: (01)07891463000378
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990172
• Device Lot Number: 3324321
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1