Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BLOOD CONTROL TECHNOLOGY; 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 BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381012
Device Problems Leak/Splash (1354); Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 08/07/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24 ga 0.75 in had a defective catheter adapter and breached sterility.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported.".
 
Manufacturer Narrative
Additional information was received which determined that the sterility was not compromised.The following fields were updated with additional information: b.5.Describe event or problem: it was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in had a defective catheter adapter.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported." f.10.Event problem codes: 1354.H.10.Device problem codes: 1354.
 
Event Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in had a defective catheter adapter.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported.".
 
Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received nine unused insyte autoguard bc 24ga units in sealed packaging and one used 24ga catheter/adapter assembly from material number (b)(4), lot number 0016718.The used catheter/adapter assembly was attached to an extension set.In addition, four photographs were submitted which displayed 24ga catheter/adapter assembly attached to an extension set.A closeup view displayed the wire through the middle of the adapter body.A visual/microscopic evaluation was performed on the nine unused units.There was no physical/mechanical damage to the any needle hub or the body of the catheter/adapter assembly.A visual/microscopic evaluation was then performed on the opened catheter/adapter assembly, which displayed a wire/metal coming through the body of the adapter near the pushed tab.The reported issue was confirmed as the adapter(hub) / connector was found defective/damaged.This was physical/mechanical evidence to confirm and support a probable manufacturing process related issue for the reported defect relating to a bent swage pin that had not been detected by the automated pin damage inspection.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 24ga 0.75in had a defective catheter adapter.The following information was provided by the initial reporter: "before use, the hcp noticed that a wire was pierced through the hub.The actual sample has been returned.No injury on the hcp or patient was reported.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key10477956
MDR Text Key206974093
Report Number1710034-2020-00549
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Catalogue Number381012
Device Lot Number0016718
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-