MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN 0,9 X 25MM; INTRAVASCULAR CATHETER

Catalog Number 38833514

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Positioning Problem (3009)

Patient Problems Extravasation (1842); Hematoma (1884)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the angiocath 22ga x 1,00in 0,9 x 25m did not have adequate lubrication and made the puncture difficult, facilitating the loss of venous access, causing leakage of blood and chemotherapeutic drugs into the patient's skin.The exposure was reportedly identified quickly, preventing further damage and major injury.The following information was provided by the initial reporter, translated from portuguese to english: peripheral intravenous catheter nº 22, the same does not have a good lubrication, making puncture difficult and facilitating that the technician loses the venous access.As the catheter do not slide correctly in the puncture, the customer lost the vein access and it was need to make new punctures.Because of that the patient had presents dilated vein and hematoma.Besides that, there was a leakage of blood and chemotherapy in the patient skin.This chemotherapy is vesicant and irritant, but there was no bigger damage because this leakage was fast identified.At the time of the loss of the vein, the patient was exposed to blood and chemotherapeutic drugs, vesicants and irritants.These medications just did not cause further damage because they were seen in time to cause any major injury.

Event Description

It was reported that the angiocath 22ga x 1,00in 0,9 x 25m did not have adequate lubrication and made the puncture difficult, facilitating the loss of venous access, causing leakage of blood and chemotherapeutic drugs into the patient's skin.The exposure was reportedly identified quickly, preventing further damage and major injury.The following information was provided by the initial reporter, translated from portuguese to english: peripheral intravenous catheter nº 22, the same does not have a good lubrication, making puncture difficult and facilitating that the technician loses the venous access.As the catheter do not slide correctly in the puncture, the customer lost the vein access and it was need to make new punctures.Because of that the patient had presents dilated vein and hematoma.Besides that, there was a leakage of blood and chemotherapy in the patient skin.This chemotherapy is vesicant and irritant, but there was no bigger damage because this leakage was fast identified.At the time of the loss of the vein, the patient was exposed to blood and chemotherapeutic drugs, vesicants and irritants.These medications just did not cause further damage because they were seen in time to cause any major injury.

Manufacturer Narrative

H.6.Investigation summary: bd received the representative sample from the same lot, the sample was tested for needle tip penetration, catheter tip penetration and drag catheter test and there was no evidence of being out of specification as reported by the customer.No objective evidence of this incident was found during the device history record and quality notifications analysis for the claimed lot, therefore, we were unable to determine an exact root cause.

• Brand Name: ANGIOCATH 22GA X 1,00IN 0,9 X 25MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8653889
• MDR Text Key: 146497369
• Report Number: 9610048-2019-00195
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 38833514
• Device Lot Number: 8270929
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other