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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381223
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Necrosis (1971); Swelling (2091)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4). There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed in sections the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that after use an unspecified bd catheter caused serious injury as the iv catheter was removed 2 days after insertion. The cat¿s paw was found with severe bruising, swelling and necrotic tissue. There was no blood supply found going to the paw, making a probable need for amputation. No further information is available regarding medical intervention or if amputation occurred.
 
Manufacturer Narrative
Investigation summary: samples/photos: samples have not received for analysis of the incident in question. Dhr/ qn/ ncmr review: the assembly lot: 7193932 produced from 07/13/2017 to 07/17/2017 in icam #02 used in the claimed final product lot: 7234928 of insyte bl 22ga x 1. 0in was analyzed for needle tip penetration, catheter tip penetration and drag catheter test, and it was not evidenced results of these tests out of specification and no other records were found that could lead to this complaint. Investigation conclusion: not confirmed: bd was unable to confirm the customer complaint for the claimed defect. In addition to the fact that no records were found that could cause this claim during the analysis of batch history and non-conformities, without samples for analysis, it is not possible to confirm the defect of irritation/ inflammation as being generated by manufacturing process.
 
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Brand NameBD INSYTE¿ PERIPHERAL VENOUS CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora NJ 07417
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7342199
MDR Text Key102512402
Report Number2243072-2018-00140
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381223
Device Lot Number7234928
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 Received02/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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