MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH PNK 20GA X 1.88IN; PERIPHERAL IV CATHETERS

Catalog Number	381137
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd angiocath pnk 20ga x 1.88in had foreign matter.The following information was provided by the initial reporter: foreign body stick on needle.Additional information provided: 1.Could you please provide the date of the event? 24 jan 2025.2.Could you please provide the number of occurrences? 1.3.Could you please provide the sample picture? 4.Kindly confirm was there any physical sample available? if yes, please provide sample tracking details.No.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381137 and lot number 4113785.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 sample was returned for evaluation by our quality team.Through examination of the picture, foreign matter with the appearance of dirt was observed in the middle of the catheter.However, for a detailed analysis and identification of the foreign matter, the physical sample would be necessary.It is possible that this incident resulted from an excessive amount of silicone during the siliconization process of the catheter.It should be noted that silicone does not cause harm to the patient/user and is used to help slide the catheter during venipuncture.It is also possible that the foreign matter is related to dirt on the walls of the machine in the grind feeding area.During the feeding of the catheter grids, when the machine vibrates (a normal process of the machine) the catheters may touch the wall and if the wall is not properly cleaned, dirt may generate on the catheter.The associates in the applicable manufacturing areas were made aware of this incident and the importance of proper cleaning of the machine to prevent any defects like this from occurring.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 PNK 20GA X 1.88IN
• 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: 21351482
• Report Number: 9610048-2025-00009
• Device Sequence Number: 7959174
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373(11)240515(17)290430(10)4113785
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 381137
• Device Lot Number: 4113785
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown