MAUDE Adverse Event Report: BECTON DICKINSON BD ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number 381137

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.D.The lot number 2209945 provided without a material number and has not been found and cannot be verified.

Event Description

It was reported that bd unknown angiocath had dirt on the needle.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024, a critical care physician planned to perform a puncture to monitor the patient's blood pressure.When preparing the puncture supplies, he found that there was dirt in the puncture needle.When he changed to another puncture needle, he found that there was still dirt (both were from the same batch).The third puncture needle was normal and reported to the equipment department as an adverse event.

Manufacturer Narrative

28 mar 2024 a sample was received with material and lot number.This supplemental provides that information.An investigation will be performed.

Event Description

Na.

Event Description

No additional information.

Manufacturer Narrative

As no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD ANGIOCATH
• Type of Device: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18664589
• MDR Text Key: 334835338
• Report Number: 2243072-2024-00141
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903811373
• UDI-Public: (01)00382903811373
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 381137
• Device Lot Number: 2209945
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/13/2024; 03/13/2024
• Supplement Dates FDA Received: 03/14/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1