• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382533
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
One sample unit was received for evaluation by our quality engineer team. Upon examination, no damage was observed to the catheter tubing, however, the adapter revealed a crack, the septum was not correctly positioned, and the needle was bent. The needle cover also displayed cracks and damages. Leakage was observed at the area of the adapter crack during testing. Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications s-au11, s-au12, s-au14, s-au15 and s-au16, in accordance with the in-process sampling plans. Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product. Bd received one used insyte autoguard unit consisting of a fully retracted needle-barrel assembly, a catheter adapter assembly, a needle cover and an open/empty package from lot number 7166897. Visual/microscopic examination showed: traces of patient residue were present throughout the unit (ex. Hub, adapter) no damage-separation was observed on the catheter tubing and the tip was acceptable per specification. The adapter revealed damage (crack, stress marks malformation) on its body and on the components on its inside (actuator) observed the septum was not positioned correctly into the assembly. The needle was put into the out position and revealed to be bent matching the damaged location observed on the catheter-adapter assembly. The needle cover revealed damaged (cracks, smashed) also matching the damaged location of the needle and the catheter-adapter assembly. Severe damage was also observed on the package which also matched locations. Water/air leak test: using a lab supplied male slip luer test fitting, performed a water/air leak test; the adapter did leak in the area of the crack. Peura analysis showed that current risk is acceptable. Occurrence and severity rankings have not changed. The unit received for evaluation revealed damage on matching locations on the catheter-adapter assembly, the needle and the needle cover, this is evidence that the damage occurred after the unit was completely assembled. Although damage was observed, the customer experience described on the event description was not confirmed. The catheter tip was intact and it did not ¿broke off¿ as stated by the customer. A definite cause that trigger the failure experienced by the customer could not be determined. It is known (according to the evidence) the damage observed occurred after a complete assembly of the units was finalized and packaged, but is if it was caused during transit or at user environment. The extent of the damage would have been noticed by the clinician prior to usage. A formal corrective action will not be initiated at this time. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported during use of the bd insyte¿ autoguard¿ bc shielded iv catheter that the end of catheter needle tip broke off upon insertion. It is reported that other actions are unknown. There was no report of injury or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7089464
MDR Text Key270068080
Report Number1710034-2017-00446
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
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 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number382533
Device Lot Number7166897
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2017
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: 12/06/2017 Patient Sequence Number: 1
-
-