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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) 22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER Back to Search Results
Catalog Number 381223
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ulceration (2116); Reaction (2414)
Event Date 09/08/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed an open ulcerative wound to right cephalic at the site of catheter insertion. The site was cultured with no growth noted. The wound was treated with "clip/clean" and bandages. There is no follow up from the patient's owner. The customer is unsure if the patient is reacting to the catheter material.
 
Manufacturer Narrative
Additional information: the actual device used in this incident is unknown. However, the customer returned samples from the following potential lot numbers: lot 2355422 - expiration date: 12/31/2017, manufacture date: 12/20/2012. Lot 5048489 - expiration date: 02/29/2020, manufacture date: 02/17/2015. Device evaluation: result - two unopened samples were returned for evaluation, one from lot 2355422 and one from lot 5048489. The returned samples were visually inspected. A cut was observed on the top web of the return samples. The sterility barrier of the returned samples could have possibly been compromised due to the cut. A process review was conducted and there is no process that could have resulted in the cut on the top web location. In addition, there is an inspection carried out after the packaging process and sharp objects are not used. Therefore, this nonconformance could have occurred out of the manufacturing facility. A review of the device history record was carried out and no abnormalities were found in the manufacture of the reported potential lot numbers. The sterility records were reviewed and no abnormality was observed. The preventive maintenance, calibration and equipment history records were reviewed and no abnormality was observed. Conclusion - an absolute root cause for this incident was not determined.
 
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Brand Name22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER
Type of DevicePERIPHERAL VENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6004750
MDR Text Key56765517
Report Number8041187-2016-00063
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other Health Care Professional
Device Catalogue Number381223
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2016
Was Device Evaluated by Manufacturer? Yes
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: 10/06/2016 Patient Sequence Number: 1
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