MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 38182314

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had "dirt" inside the sealed packaging before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "peripheral intravenous catheter with safety device 22g, lot 8298682, with presence of dirt in the catheter inside the sealed package.".

Manufacturer Narrative

Investigation: dhr review: this lot was reviewed regarding the tests of ¿foreign matter¿ and were not evidenced records for this claimed defect.It was received one sample of insyte autoguard 22g at bd juiz de fora, on (b)(6) 2019, lot: 8298682 in original and open package.The sample was visually analyzed and it was verified that the foreign matter on the outside of the shield, since the shield is a molded component in sandy from bulk comes to juiz de fora assembly line.Based on the results of the investigation to date a root cause has not been determined for the defect described in this complaint since the protector is a component molded in sandy from comes bulk to assembly line from juiz de fora.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had "dirt" inside the sealed packaging before use.The following information was provided by the initial reporter, translated from portuguese to english: "peripheral intravenous catheter with safety device 22g, lot 8298682, with presence of dirt in the catheter inside the sealed package.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8496288
• MDR Text Key: 141465981
• Report Number: 9610048-2019-00147
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 38182314
• Device Lot Number: 8298682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other