MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381223

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation conclusion: samples/ photos: according to the visual analysis of the photo containing the claimed sample, it was possible to identify that the component (filter plug) was loose inside the package of product.Dhr review: the insyte assembled in icam #02 in the period between 04 and (b)(6) 2017, lot: 7087519, used in the final product lot: 7118890 of insyte 22g 1,00 was analyzed regarding the test of "loose filter plug" and were not evidenced records that could lead to the claimed defect.However, a note dated (b)(6) 2017 was noted which describes: "broken claw spring, station # 18, track #1, chassis # 2" that may have led to this complaint.The packaged lot: 7118890 was manufactured in r530-2 machine on (b)(6) 2017 and no records of "missing component" were evidenced.Qn/ ncmr review: there are no quality notification (qn) or nonconformity report of "loosen filter plug¿ or something that could lead to this complaint.Unplanned maintenance: during the investigation, the history of corrective maintenance during the assembly period of the batch involved in this claim was evaluated.As a result of this analysis, corrective maintenance record #(b)(6) was performed on (b)(6) 2017 for the following reason: "broken spring of the claw est-18 track-1 # 2" that might have led to the incident in question root cause description: our quality engineer was able to verify the component (filter plug) was loose inside the package of product.The root cause for the issue is due to the breaking of the claw of a machine which led to poor placement of the plug in the hub.A corrective action was performed by changing the spring and adjusting the claw position.

Event Description

It was reported that before use a bd insyte¿ peripheral venous catheter malfunctioned as "after opening, the plastic tip came off and fell." there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD INSYTE¿ PERIPHERAL VENOUS CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7477896
• MDR Text Key: 107600213
• Report Number: 9610048-2018-00056
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812234
• UDI-Public: 30382903812234
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 381223
• Device Lot Number: 7118890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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
• Patient Outcome(s): Other