MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ 5ML SYRINGE; PISTON SYRINGE

Catalog Number 990175

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/09/2023

Event Type  malfunction  

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

It was reported while using bd plastipak¿ 5ml syringe the seal was not sterile.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: today, (b)(6)2023, the surgical center reported that when opening the package of syringes, they observed that some of them had the sterilization seal open.Sealing is essential to ensure proper sterilization and product safety.

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: 11-sep-2023.H.6.Investigation summary: six samples, photos, and video received by our quality team for investigation.Through visual inspection, it is observed the package seal integrity is affected.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 team¿s investigation, it is possible to confirm that the opened packages were caused by the film failure.Installation / validation of film sensors will be implemented.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 while using bd plastipak¿ 5ml syringe the seal was not sterile.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: today, (b)(6) 2023, the surgical center reported that when opening the package of syringes, they observed that some of them had the sterilization seal open.Sealing is essential to ensure proper sterilization and product safety.

Manufacturer Narrative

Correction: dhr investigation summary: six samples, photos, and video received by our quality team for investigation.Through visual inspection, it is observed the package seal integrity is affected.A device history review was performed for lot 2290563, maintenance record related to the incident is observed.Retention samples from the same lot were evaluated, no defects or issues observed.Based on the team¿s investigation, it is possible to confirm that the opened packages were caused by the film failure.Installation / validation of film sensors will be implemented.We appreciate you taking the time to bring this observation to our attention.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

No additional information received.Today, 8/9/23, the surgical center reported that when opening the package of syringes, they observed that some of them had the sterilization seal open.Sealing is essential to ensure proper sterilization and product safety.___ customer provided to us the additional information below.¿ through the photos it was not possible to identify the batch(es) of the product.Could you please inform the batch(es) affected? there are five units in lot: 990175.According to the video received we will considering the batch 2290563.¿ in how many units was the deviation identified? 7 units.¿ was any syringe ever used on a patient? no.¿ was there any harm to the patient/caregiver? (detail) no.¿ was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, drug administration, etc.)? (detail) no.¿ could you forward photos and/or videos showing the labels on the box where the syringes came from? please see attached.¿ is the sample related to the incident available for analysis? if so, how many units? (we collect a maximum of 10 units for analysis purposes) yes, they are available.**** on 27.Sep.2023, customer provides the following: ¿ through the photos we identified the catalog 990175, could you confirm if it is correct? are there any other catalogs involved in the complaint? r: it's correct, i confirm there are no other materials involved in the complaint.((b)(6), (b)(6) 2023).

• Brand Name: BD PLASTIPAK¿ 5ML 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: 17628069
• MDR Text Key: 322021315
• Report Number: 3003916417-2023-00251
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463001771
• UDI-Public: (01)07891463001771
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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