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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

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382534
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/02/2021
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the catheter broke/separated from the hub.The following information was provided by the initial reporter.The customer stated: "on removal of an arterial line in icu on (b)(6) 2021, it was identified the tip of the arterial line was not intact.The tip was surgically removed and the tip preserved.".
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the catheter broke/separated from the hub.The following information was provided by the initial reporter.The customer stated: "on removal of an arterial line in icu on (b)(6) 2021, it was identified the tip of the arterial line was not intact.The tip was surgically removed and the tip preserved.".
 
Manufacturer Narrative
The investigation found that the returned sample was not a 20g x 1.16in.Catheter.Measurements suggested the catheter could be from a 20g x 1.88in.Unit.This supplemental is to capture the unknown material number for the returned sample.H.6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used insyte autoguard catheter tubing with no product documentation or packaging.A gross visual inspection of the returned sample found that the catheter tubing length was larger than the length of the reported product.The reported material number was for a 20g x 1.16in.Catheter.A measurement with a ruler found that the returned catheter tubing measured 1.80 inches, indicating that the catheter was likely a 20g x 1.88in.Unit as that is the only larger size available for a 20g unit.The total length of the catheter tubing for a 20g x 1.88in.Unit, including the material inside the nose of the adapter, is larger than 1.88 inches.As the returned sample was only 1.80 inches in length, it was concluded that the returned sample was missing some material.Microscopic inspection found that the missing end of the catheter tubing had an angled shape.The surface with the missing end was mostly a smooth surface with sections of rough surface near the outer diameter.This indicated that the catheter was likely partially cut by a sharp instrument, creating the smooth surface, and then experienced tensile stress that broke the catheter tubing, causing the rough surface.Based on appearance and shape of the cut, the most likely root cause was determined to be coming into contact with a sharp instrument (e.G., scissors) during use.Scissors or other sharp instruments may damage the catheter if used at or near the insertion site.It is also possible the damage could have occurred due to the needle piercing through the catheter during venipunture; however, the characteristic v-shaped cut was not present.Also, it is unlikely that the torn edge of the tubing would look smooth and uniform if the flexible tubing material was bent, stretched, and pulled over time.A device history record review could not be performed as the lot number is unknown.H3 other text : see h.10.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12830602
MDR Text Key280947649
Report Number1710034-2021-00992
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825340
UDI-Public30382903825340
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382534
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2021
Initial Date FDA Received11/17/2021
Supplement Dates Manufacturer Received12/06/2021
Supplement Dates FDA Received01/13/2022
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 Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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