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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
Catalog Number 382523
Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)
Patient Problem No Information (3190)
Event Date 04/20/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 when removing a bd insyte¿ autoguard¿ bc shielded iv catheter from the left ac of patient in the emergency center, the nurse was met with resistance.When pulling further, she noticed that the hub came off but the catheter tubing had broken off in the patient.A physician was called and catheter was surgically removed.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: unknown; event attributed to: other; device single use?: no; device returned to manufacture: no.
 
Event Description
It was reported when removing a bd insyte autoguard bc shielded iv catheter from the left ac of patient in the emergency center, the nurse was met with resistance.When pulling further, she noticed that the hub came off but the catheter tubing had broken off in the patient.A physician was called and catheter was surgically removed.
 
Manufacturer Narrative
Investigation summary: device/batch history record review was performed on the lot number: 8019968.The lot number was built/package on afa line 12, from january 20, 2018 thru january 25, 2018.Review of the dhr revealed all required challenges samples and testing was performed per specification 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.Qn/sap database review revealed no related reject activity for the lot number associated with this incident.The peura (end user risk analysis) was analyzed to determine the risk to customer and found to be acceptable due to low occurrence rate.Visual/microscopic examination: although observations and testing could not be performed because a sample was not received for investigation, there were 10 photos submitted for review.Photo 1 displayed a bd syringe attached to a needleless connector attached to an extension set attached to 22 ga catheter/adapter photo 2 displayed a 22ga catheter/adapter and part of the needless connector photo 3 displayed the same as photo 2 photo 4 displayed a bd syringe attached to a needleless connector attached to an extension set attached to 22 ga catheter/adapter along with a loose 22ga catheter/adapter.Photo 5 displayed a bd syringe attached to a needleless connector attached to an extension set attached to 22 ga catheter/adapter along with a loose 22ga catheter/adapter.Photo 6 displayed a bd syringe attached to a needleless connector attached to an extension set attached to 22 ga catheter/adapter along with a loose 22ga catheter/adapter.Photo 7 displayed a bd syringe attached to a needleless connector attached to an extension set attached to 22 ga catheter/adapter along with a loose 22ga catheter/adapter.Photo 8 displayed a bd syringe attached to a needleless connector attached to an extension set attached to 22 ga catheter/adapter.Photo 9 displays the 22ga catheter/adapter.Photo 10 displays the 22ga catheter/adapter.The returned photos provided for evaluation revealed the used catheter/adapter was slightly shorter in length than the representative sample used in the comparison.The defect catheter broke/separated after placement; as stated as the reported code was confirmed based on the photos with the used catheter/adapter and a representative sample.The information provided does not provide evidence that the catheter was not functioning correctly during the period of infusion.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.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.
 
Event Description
It was reported when removing a bd insyte¿ autoguard¿ bc shielded iv catheter from the left ac of patient in the emergency center, the nurse was met with resistance.When pulling further, she noticed that the hub came off but the catheter tubing had broken off in the patient.A physician was called and catheter was surgically removed.
 
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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
MDR Report Key7512639
MDR Text Key108224379
Report Number1710034-2018-00197
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825234
UDI-Public30382903825234
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 09/05/2018
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 Nurse
Device Expiration Date12/31/2020
Device Catalogue Number382523
Device Lot Number8019968
Initial Date Manufacturer Received 04/20/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received04/20/2018
04/20/2018
Supplement Dates FDA Received08/01/2018
09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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