MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER 24G X 0.75 IN

Catalog Number 383403

Device Problem Leak/Splash (1354)

Patient Problems Erythema (1840); Unspecified Infection (1930); Staphylococcus Aureus (2058); Swelling (2091)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluation: a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the patient had hand-foot-and-mouth disease and was hospitalized on (b)(6) 2016.The patient was receiving an infusion of mannitol through the suspect device, which was inserted in the right ankle.On the evening of (b)(6) 2016, the site was noted to be leaking so the infusion site was changed to the left ankle.The following day, the right ankle became red and swollen at the insertion site and an effusion was noted.It was reported that "relevant action was taken".The device was removed from the left ankle when the infusion was complete.On (b)(6) 2016, the patient was receiving an infusion to a right hand vein when the site became red and swollen.On (b)(6) 2016, the insertion point near the left ankle suppurated.The blood cultures showed staphylococcus aureus.The hip joint also became infected and the patient was transferred to (b)(6) for further treatment.No additional information was available at the time of report.

Manufacturer Narrative

Pt sex: male.Describe event or problem: after midnight on (b)(6) 2016, the device was removed from the right ankle.The device was placed to the right radial vein on (b)(6) 2016 to resume the mannitol therapy, which became red and swollen and pus was noted at the site.This was treated "by taking corresponding actions".On (b)(6) 2016, the insertion site of the posterior ankle vein "was broken and discharged pus".On (b)(6) 2016, the insertion site of the left ankle vein was also found "broken and discharged pus".Per report "the hospital had to rule our the causes leading to infection at each stage but could not test whether sterilization of the iv catheter was incomplete." device evaluation: result - two unused devices from the reported lot number 6084289 were returned for evaluation.The returned material did not show the reported defect.A review of the device history record revealed no abnormalities during on assembly, packaging and sterilization, bi sterility tests and eo residual tests.Per a manufacturing review, no related issues were found during production.Conclusion - bd was not able to confirm the customer's indicated failure.No abnormalities were found during eo sterilization and eo residual and sterility tests met requirements.Per the bd engineer, "many factors lead to (the) complaint phenomenon, including device contamination, sterile operation environment, medical devices, medicine, patient¿s vessel condition etc.In this case, mannitol is a hypertonicity drug, which can stimulate vessels and cause phlebitis." an absolute root cause for this incident cannot be determined.

Event Description

After midnight on (b)(6) 2016, the device was removed from the right ankle.The device was placed to the right radial vein on (b)(6) 2016 to resume the mannitol therapy, which became red and swollen and pus was noted at the site.This was treated "by taking corresponding actions".On (b)(6) 2016, the insertion site of the posterior ankle vein "was broken and discharged pus".On (b)(6) 2016, the insertion site of the left ankle vein was also found "broken and discharged pus".Per report "the hospital had to rule our the causes leading to infection at each stage but could not test whether sterilization of the iv catheter was incomplete.".

• Brand Name: BD INTIMA II¿ IV CATHETER 24G X 0.75 IN
• Type of Device: IV CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5950178
• MDR Text Key: 54699622
• Report Number: 3006948883-2016-00024
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 383403
• Device Lot Number: 6084289
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO