MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 38181114

Device Problem Nonstandard Device (1420)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 there was a device with an incorrect color with the bd insyte¿ autoguard¿ shielded iv catheters.The following was translated from portuguese to english.Where it points out by photographic evidence that the barrel of one of the catheters came with a different color and there was an empty space missing the catheter.

Manufacturer Narrative

A device history record review was completed for provided material number 38181114 and lot number 3009534.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, three (3) picture samples were received for evaluation by our quality team.Through examination of the pictures, it was possible to identify a 20g product inside of the 24g blister package as well as one empty package.A review of the production history showed that the product run on the manufacturing lines prior to 24g material 38181114, was the 20g insyte autogaurd product shown in the picture sample.This mix of product can be attributed to an error in the line clearing and detection process.There was also a failure to detect the empty package.This is the first complaint received for this type of defect for lot number 3009534.Awareness training for the packaging area personnel has been proposed in response to this incident as well as a quality notification for the device history records.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

Where it points out by photographic evidence that the barrel of one of the catheters came with a different color and there was an empty space missing the catheter.____ customer provided to us the additional information below.- in total, how many units had this deviation? 2 units - was the deviation noticed before use? before use.- is there any damage to the product packaging? deviation in sealed packaging.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora UT ; BR
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17692732
• MDR Text Key: 322763060
• Report Number: 1710034-2023-01020
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818112
• UDI-Public: 00382903818112
• 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: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38181114
• Device Lot Number: 3009534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• 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