MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD¿TAMPA SERING LUER CAP; INJECTION CAP

Catalog Number 990731

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that there was a hole in a bd¿tampa sering luer cap.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: two opened and unused samples of were received for investigation.After visual analysis, it can be verified that both samples had holes, which characterize incomplete piece coming from the molding of this component.Dhr review: the following molding batch used in the final claimed product list 7300933 was analyzed: the molding lot: 7271547 was produced in the period from 02 to 10/06/2017 in the injection machine #40024449, position 7.The batch in question was analyzed for the tests to verify "hole in the part" or ¿incomplete part¿ and no record of this defect was evidenced during the analysis.It was reviewed the lot 7300933 for the component damaged in the package and no records of this type of defect were found.Investigation conclusion: confirmed: bd was able to confirm the complaint based on the analysis of the customer's photo containing the claimed defect.Based on the results of the investigation the root cause of the incident in question is due to variations in the injection process of the hydraulic injector used to mold this component.A punctual variation in dosage, injection rate, injection pressure or settling pressure individually or in combination can lead to this problem in a given injection cycle.

• Brand Name: BD¿TAMPA SERING LUER CAP
• Type of Device: INJECTION CAP
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 7378497
• MDR Text Key: 103823544
• Report Number: 9610048-2018-00027
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K834480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 990731
• Device Lot Number: 7300933
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other