MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE PLASTIPAK 5ML S/SU

Catalog Number 990175

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that the bd syringe plastipak 5ml s/su package seal integrity was poor/questionable.The following information was provided by the initial reporter, translated from portuguese to english."today, 10/24/23, the surgical center reported that when opening the package of syringes, they observed that some of them had the sterilization seal open.8 units.Syringe with broken seal.".

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

Additional information received: customer provided to us the information below.Have any syringes been used on a patient? no.Was there any harm to the patient/healthcare professional? (detail) no.Was there a need for medical and/or surgical intervention due to what happened (imaging exams, surgery, medication administration, etc.)? (detail) no.Is the incident-related sample available for analysis? if so, how many units? (we collect a maximum of 10 units for analysis purposes) yes.Was there notification to anvisa? if so, what is the notification number? yes, (b)(4).

Manufacturer Narrative

Investigation summary: eight samples and photos received by our quality team for investigation.Through visual inspection, packaging seal integrity appears compromised.Furthermore, a device history record review showed maintenance records related to the incident reported.Possible root cause is associated with failure of film during the packaging process.Action will be implemented including installation and validation of film sensors.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.

• Brand Name: BD SYRINGE PLASTIPAK 5ML 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: 18167270
• MDR Text Key: 328631307
• Report Number: 3003916417-2023-00327
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990175
• Device Lot Number: 2290563
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1