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

Catalog Number 38831214

Device Problems Material Puncture/Hole (1504); Device Damaged Prior to Use (2284)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

It was reported while using bd insyte¿ iv catheter the catheter tip was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: when opening the medical device, it is observed that it is with damaged point.

Manufacturer Narrative

Age or date of birth: patient¿s birthday was not provided, (b)(6) 2019 was used based on age of patient.Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: b5: describe event or problem: it was reported while using bd insyte¿ iv catheter the needle was through catheter while introducing the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: when opening the medical device, it is observed that it is with damaged point.H5:imdrf annex a grid: a041001 h6: investigation summary a device history record review was completed for provided material number 38831214 and lot number 2145963.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, one (1) picture was provided for evaluation by our quality engineer team.Through examination of the picture, the needle was observed through the catheter.It is possible that this incident resulted from an improper adjustment in the manufacturing station which led to improper fittings for the catheter length.It is also possible that the vision system in place was not properly configured.

Event Description

It was reported while using bd insyte¿ iv catheter the needle was through catheter while introducing the catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: when opening the medical device, it is observed that it is with damaged point.

• Brand Name: BD INSYTE¿ 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
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16728486
• MDR Text Key: 313202294
• Report Number: 9610048-2023-00036
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/20/2023

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: 38831214
• Device Lot Number: 2145963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 05/20/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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 Age: 4 YR
• Patient Sex: Female