MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	38184414
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard needle pierced the catheter.The following information was provided by the initial reporter, translated from portuguese to english: notification was opened with the notivisa due to a possible deviation from the quality, when trying to puncture avp with the abocath n 22 of the bd insyte autoguard brand, i felt resistance in the conduction of the abocat and without venous return.I remove the catheter and realize that the mandrel has perforated the silicone, generating another puncture in the child and risk of injury to the vessel.24 oct 2024 several complaints were reported with the same justification.However, only 2 units were notified.There was no harm to the patient/health professionals.And we don't have samples available for collection.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
A device history record review was completed for provided material number (b)(4) and lot number 3363156.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.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.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 or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information received: b, event date updated e.Initial reporter occupation updated.
Event or Problem Description
Received on 07nov2024.Could you please provide event date for 2 units? the events were reported on 08/28/2024.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20594283
• Report Number: 9610048-2024-00168
• Device Sequence Number: 18342061
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: (01)00382903818440(11)240206(17)261231(10)3363156
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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: Other
• Device Catalogue Number: 38184414
• Device Lot Number: 3363156
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided; 02/18/2025
• Initial Report FDA Received Date: 11/02/2024
• Supplement Report FDA Received Date: 11/13/2024; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown