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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383403
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 06/19/2016
Event Type  Injury  
Manufacturer Narrative
Sample is available for evaluation. Upon completion of investigation, a supplemental report will be filed. Results: one used sample was returned for evaluation. A visual inspection revealed a broken catheter with a clump of hair on the medical tape. A microscopic inspection revealed that the catheter was broken at approximately 1. 5 mm from the catheter adapter. The broken section was at a 45 degree angle and was smooth with no pull marks. A simulation test was done by cutting a representative catheter with a knife and the same findings were observed as what was seen on the returned investigation sample. Five retention samples were evaluated and all samples were found to be within specification. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6018457.
 
Event Description
"it was reported that on (b)(6) 2016 at approximately 20:00, a bd intima-ii closed iv catheter, size unknown, was placed in a child's scalp for infusion. The patient was taken home after the infusion was completed, with the catheter still in place. Within the hour, the parents found that the catheter had broken off at the hub. They returned to the hospital, where the child was given a ct scan. On the morning of (b)(6) 2016, the broken-off catheter was removed surgically. ".
 
Manufacturer Narrative
Results: one used sample was returned for evaluation. A visual inspection revealed a broken catheter with a clump of hair on the medical tape. A microscopic inspection revealed that the catheter was broken at approximately 1. 5 mm from the catheter adapter. The broken section was at a 45 degree angle and was smooth with no pull marks. A simulation test was done by cutting a representative catheter with a knife and the same findings were observed as what was seen on the returned investigation sample. Five retention samples were evaluated and all samples were found to be within specification. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6018457. Conclusion: an absolute root cause for this incident cannot be determined. However, our quality engineer notes that the observed catheter break appears to have been cut by a sharp object outside of the manufacturing facility as the sample passed a 100% visual inspection during the manufacturing process.
 
Manufacturer Narrative
Corrected catalog number from #383408 to #383403.
 
Event Description
On 7/13/2016, additional information was provided for this incident. It was reported that the suspect device was 24g bd intima-ii¿ closed iv catheter, the initial iv insertion process was smooth with no need for a no secondary puncture, and surgical removal of the broken catheter was performed under general anesthesia.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER
Type of DeviceINTRAVASCULAR 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 Key5784381
MDR Text Key49234872
Report Number3006948883-2016-00020
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,Followup,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number383403
Device Lot Number6018457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/11/2016 Patient Sequence Number: 1
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