MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	382259
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd angiocath foreign body was noted inside of the catheter cap/shield.The following information was provided by the initial reporter: before using this product, i found what appeared to be insects in the protective cover.One unit was affected.(b)(6).2.Was the foreign matter located within sterile unit package or inside of the cap/shield on the catheter/needle itself? the fm is located inside the catheter protective sleeve.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 photos and 1 physical sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the samples.Analysis of the sample showed that although it was mentioned the foreign matter appeared to be insects it was analyzed with a microscope and it was confirmed that the particle was plastic.Bd was not able to determine where the plastic particle came from as ftir testing was inconclusive in identifying the particle.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.

• Brand Name: ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22806890
• Report Number: 9610847-2025-00251
• Device Sequence Number: 7798411
• Product Code: FOZ
• UDI-Device Identifier: 00382903822591
• UDI-Public: (01)00382903822591(17)290531(10)4144324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: 382259
• Device Lot Number: 4144324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown