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

Catalog Number	381112
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd angiocath needle pierced the catheter resulting in bent needle with retraction difficulties.The following information was provided by the initial reporter, translated from italian to english: placement of iv infusion cannula needle in support feeding in preterm infant.Preparation of necessary materials.Disinfection of the site.Maneuver performed by two operators.Visualization of the venous heritage and attempt do access placement.Unsuccessful placement of access.In retracing the device perception of difficulty and resistance to remove it.Once out, later after several attempts, the cannula shows up bent and punctured by the guide needle.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381112 and lot number 3103354.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, the affected physical sample was returned for evaluation by our quality team.Through examination of the sample, the needle was observed through the catheter.It is most probable that this defect resulted from the catheter being bent and the air blowing station being incorrect during manufacture.There was also a failure in the vision system and the detection inspection which allowed the catheter to pass through to the client.Associates in the product assembly and packaging areas have been alerted of this incident to raise further awareness on the production floor.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.

• Brand Name: BD ANGIOCATH
• 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: 20598683
• Report Number: 9610048-2024-00170
• Device Sequence Number: 6550893
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120(11)230427(17)280331(10)3103354
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: Health Professional
• Device Catalogue Number: 381112
• Device Lot Number: 3103354
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown