MAUDE Adverse Event Report: BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381137

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd angiocath¿ iv catheter experienced leakage.The following information was provided by the initial reporter: on (b)(6) 2021, the patient accidentally injured his head in a car accident at noon this afternoon.He was not in a coma at the time.After the injury, he felt headache and dizziness.No limb twitching, she was rushed to the hospital for medical treatment.A ct scan of the brain this afternoon revealed postoperative changes in the right cranium, abnormal changes in the right skull, and ischemic changes in the right temporal lobe.Chest ct showed bronchial disease and a few fibrous inflammatory foci in both lungs.Ct of the left knee revealed a comminuted fracture of the upper end of the left tibia; a fracture of the upper part of the left fibula.On (b)(6) 2021 21:15 ct full abdomen scan (upper abdomen + lower abdomen + pelvic plain scan) abdominal ct scan, there are no obvious traumatic lesions of liver, spleen and kidney at present; follow-up.Fractures of the left sacrum and ilium, accompanied by swelling of the soft tissues of the left presacrum.The upper and lower branches of the pubic bone were fractured with swelling of surrounding soft tissues.The density of the inguinal canals on both sides increased.Degenerative changes of the lumbar spine, no obvious compressive changes have been seen so far.On (b)(6) 2021 21:16 ct plain cervical scan (every three vertebrae) cervical degenerative changes.On (b)(6) 2021 21:21 ct plain cranial scan (ct) postoperative changes of the right cranium.Hematoma formed in the right temporal lobe.For a small amount of subarachnoid hemorrhage, he was admitted to the hospital for "brain contusion" for further treatment.At 2:40 pm on (b)(6) 2021, a single-use intravenous indwelling needle was used to infuse the patient.During the inspection at 5:00, the nurse found that it occurred blood leakage during the one-time use of the intravenous indwelling needle.The transparent applicator was immediately removed and the disposable intravenous indwelling needle was removed.The puncture site was pressed with a cotton ball for 3 minutes.Check the pink upper part of the disposable intravenous indwelling needle to cause oozing.Need to re-puncture the indwelling in the next infusion.

Event Description

It was reported that the bd angiocath¿ iv catheter experienced leakage.The following information was provided by the initial reporter: on (b)(6) 2021, the patient accidentally injured his head in a car accident at noon this afternoon.He was not in a coma at the time.After the injury, he felt headache and dizziness.No limb twitching, she was rushed to the hospital for medical treatment.A ct scan of the brain this afternoon revealed postoperative changes in the right cranium, abnormal changes in the right skull, and ischemic changes in the right temporal lobe.Chest ct showed bronchial disease and a few fibrous inflammatory foci in both lungs.Ct of the left knee revealed a comminuted fracture of the upper end of the left tibia; a fracture of the upper part of the left fibula.On (b)(6) 2021 21:15 ct full abdomen scan (upper abdomen + lower abdomen + pelvic plain scan) abdominal ct scan, there are no obvious traumatic lesions of liver, spleen and kidney at present; follow-up.Fractures of the left sacrum and ilium, accompanied by swelling of the soft tissues of the left presacrum.The upper and lower branches of the pubic bone were fractured with swelling of surrounding soft tissues.The density of the inguinal canals on both sides increased.Degenerative changes of the lumbar spine, no obvious compressive changes have been seen so far.(b)(6) 2021 21:16 ct plain cervical scan (every three vertebrae) cervical degenerative changes.On (b)(6) 2021 21:21 ct plain cranial scan (ct) postoperative changes of the right cranium.Hematoma formed in the right temporal lobe.For a small amount of subarachnoid hemorrhage, he was admitted to the hospital for "brain contusion" for further treatment.At 2:40 pm on (b)(6) 2021, a single-use intravenous indwelling needle was used to infuse the patient.During the inspection at 5:00, the nurse found that it occurred blood leakage during the one-time use of the intravenous indwelling needle.The transparent applicator was immediately removed and the disposable intravenous indwelling needle was removed.The puncture site was pressed with a cotton ball for 3 minutes.Check the pink upper part of the disposable intravenous indwelling needle to cause oozing.Need to re-puncture the indwelling in the next infusion.

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12316573
• MDR Text Key: 266366311
• Report Number: 9610048-2021-00114
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903811374
• UDI-Public: 30382903811374
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381137
• Device Catalogue Number: 381137
• Device Lot Number: 0233711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1