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

Catalog Number	381223
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ iv catheter was broken at the tip.The following information was provided by the initial reporter: this feedback from operating room of anesthesia department.Nurses complained that the needle is blunt when inserting iv catheter.When failing in inserting catheter, nurse withdrew catheter and saw that the catheter was broken at the tip.Catheter broken at the tip: nurses concern may happen the situation that drop in the vein of patient and stuck somewhere in circulatory system (currently didn't happen this situation with bd catheter but happened with other catheter from competitor (india brand) so when the catheter broken at the tip, nurse have such concern) needle is blunt: nurses complaint that difficult to insert iv cannula in the vein, create pain to patient and nurse can't use that catheter anymore, waste hospital's budget.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 20-jul-2023.H.6.Investigation summary: our quality engineer inspected the 1 photo and 4 samples from batch 2234330 submitted for evaluation.The reported issue of needle dull / blunt was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that there was no damages or abnormalities on the needle of the devices.All the samples underwent cannula penetration testing and all samples for batch 2234330 passed with no defect.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter was broken at the tip.The following information was provided by the initial reporter: this feedback from operating room of anesthesia department.Nurses complained that the needle is blunt when inserting iv catheter.When failing in inserting catheter, nurse withdrew catheter and saw that the catheter was broken at the tip.Catheter broken at the tip: nurses concern may happen the situation that drop in the vein of patient and stuck somewhere in circulatory system (currently didn't happen this situation with bd catheter but happened with other catheter from competitor (india brand) so when the catheter broken at the tip, nurse have such concern) needle is blunt: nurses complaint that difficult to insert iv cannula in the vein, create pain to patient and nurse can't use that catheter anymore, waste hospital's budget.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter was broken at the tip.The following information was provided by the initial reporter: this feedback from operating room of anesthesia department.Nurses complained that the needle is blunt when inserting iv catheter.When failing in inserting catheter, nurse withdrew catheter and saw that the catheter was broken at the tip.Catheter broken at the tip: nurses concern may happen the situation that drop in the vein of patient and stuck somewhere in circulatory system (currently didn't happen this situation with bd catheter but happened with other catheter from competitor (india brand) so when the catheter broken at the tip, nurse have such concern) needle is blunt: nurses complaint that difficult to insert iv cannula in the vein, create pain to patient and nurse can't use that catheter anymore, waste hospital's budget.
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of catheter tip integrity was not confirmed upon inspection of the photo, but the defect of needle through catheter was observed.Upon review of the sample photo, it can be observed that the needle had pierced the catheter.A root cause for the failure could not be determined for this incident.A device history review could not be completed as no batch number was provided.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora DE
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora DE
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16916199
• Report Number: 9610048-2023-00047
• Device Sequence Number: 19380405
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: (01)00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 08/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/27/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown