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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD INTIMA II¿ IV CATHETER 24G X 0.75 IN Back to Search Results
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. ".
 
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Brand NameBD INTIMA II¿ IV CATHETER 24G X 0.75 IN
Type of DeviceIV 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 Key5950178
MDR Text Key54699622
Report Number3006948883-2016-00024
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K100775
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
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 Received09/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Catalogue Number383403
Device Lot Number6084289
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/14/2016 Patient Sequence Number: 1
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