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

Catalog Number 990174

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

It was reported that 1 bd plastipak¿ luer-lok¿ syringe from lot 1288443, and 2 syringes from lot 9196093 had issues with their packaging units having holes in them.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: " lot 1288443 of 11 units how many units were found with: hole: 1.Lot: 9196093 of 3 units how many units were found with: hole: 2".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1288443.Medical device expiration date: 31-oct-2026, device manufacture date: 15-oct-2021.Medical device lot #: 9196093, medical device expiration date: 31-jul-2024, device manufacture date: 22-jul-2019.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 05-sep-2022.H6: investigation summary: samples and photos received by our quality team for investigation.Upon visual inspection of samples for batch 9196093, a foreign body with an orange color was found on one side of the package and, on the other side, a dark shadow at the bottom of the package.Microscopic analysis was performed, orange foreign matter was identified as rust.The other foreign matter was not identified, during the tests the matter was associated to a shadow, therefore it was not possible to test/reproduce the issue.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.Retention samples from the same lot were evaluated for package damaged, no defects or issues observed.

Event Description

It was reported that 1 bd plastipak¿ luer-lok¿ syringe from lot 1288443, and 2 syringes from lot 9196093 had issues with their packaging units having holes in them.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: " lot 1288443 of (b)(6) units.How many units were found with: hole: 1.¿ lot: 9196093 of (b)(6) units.How many units were found with: hole: 2.".

• 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: 15249542
• MDR Text Key: 305375801
• Report Number: 3003916417-2022-00155
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990174
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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