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

Catalog Number	381123
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
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 catheter separated or broke; retained object.The following information was provided by the initial reporter: a serious incident that occurred with a patient, where the plastic part of the iv cannula was retained in the patient¿s vein after removing her iv line.The patient was admitted to the emergency department on (b)(6) 2024 at 5:20pm, complaining from persistent bleeding from the site of the iv insertion she had that same day at cmc; left hand foreign body was suspected, confirmed and removed by a surgeon.Most probably that the cannula was detached from the blue tip of the angiocath.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Additional information/clarification received on 1 jul 2024 where the correct lot number is provided.Lot mfg/exp dates updated.
Event or Problem Description
No additional information for this incident.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381123 and lot number 2202917.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, five (5) picture samples were received for evaluation by our quality team.Through examination of the pictures, it was possible to identify that the catheter is breaking.For a detailed analysis, it would be necessary to have a picture of the adapter (blue cannon) and/or the presence of the physical sample.At this time, an exact cause could not be determined for this incident.For the defect of catheter breakage/separation after placement, a corrective and preventive action plan has been initiated for further investigation and to prevent any potential reoccurrence.

• 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 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19308975
• Report Number: 9610048-2024-00052
• Device Sequence Number: 7004236
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: (01)00382903811236
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 381123
• Device Lot Number: 2202917
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: Not provided; 09/26/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/02/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown