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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¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381823
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative
Results: two sample units were received for evaluation by our quality engineer team. Upon examination, no damage was observed to the first unit and the second unit had a piece of catheter tubing separated with rough edges. It is uncertain whether the defect observed on unit two was caused by manipulation of the device prior to insertion or after insertion. The rough edges on the separated pieces of tubing are an indication of tensile stress on the catheter tubing. Lot analysis. Device/batch history record review: no. Reason: although the investigation is mdr, the lot number associated with the incident was not reported. Findings: n/a sap (qn) database review: no. Reason: this database tracks any issue during production that would affect product quality. Findings: subject code was an s3 severity ranking. Review was not conducted for this mdr- level b investigation because a lot number was not provided for this incident. The peura (end user risk analysis): yes. Reason: the peura is required for all mdr reportable investigations. Findings: rm5835 revision 12 version j was reviewed and determined to have appropriate assessment of risk related to this defect. Visual analysis. Observations and testing: received two used 22g insyte autoguard iv catheter/adapter units and a medicine container with a piece of catheter tubing in it. Visual/microscopic evaluation revealed: unit 1: observed there was traces of blood residue on the catheter tubing, inside the adapter (wedge/tubing assembly area), no damage was observed on any of its components and the catheter tubing was intact (no holes, cuts or defects). (b)(4). Unit 2: observed there were traces of blood residue on the catheter tubing, inside the adapter (wedge/tubing assembly area) and on the wings. Observed there was approximately 11mm of catheter tubing (from the nose of the adapter to the highest point of the tubing) and the catheter tip was separated, the piece of catheter tubing received in the medicine container matched the tubing on the adapter, the area of separation at the catheter tubing had rough edges on both of the pieces of the catheter tubing. (b)(4). Water-leak test: the water leak test was performed only on unit 1, no leakage was observed on any of the areas of the unit confirming no damage was present. Investigation samples(s) meet manufacturing specifications: no. Unit 2 separation on the catheter tubing was observed. The area of separation at the catheter tubing had rough edges on both of the pieces received. Conclusions: no defects were found on unit 1. The defect of catheter broke, as stated in the product incident report was confirmed with unit 2. The area of separation at the catheter tubing had rough edges on both of the pieces received, an indication of tensile stress on the catheter tubing. Did the evaluation confirm the customer¿s experience with the bd product? yes: the defect experienced by the customer was confirmed on unit 2. Were we able to reproduce the customer's experience with the bd product? no: the customer¿s experience was not reproduced in the laboratory environment. Was the device used for treatment or diagnosis? treatment. Conclusion: root cause relationship of device to the reported incident: indeterminate. Comment: it is uncertain whether the defect observed on unit 2 was caused by manipulation of the device prior to insertion or after insertion. The rough edges on the separated pieces of tubing are an indication of tensile stress on the catheter tubing. According to the customer statement ¿they moved the 1st needle to the front and the rear¿ which could have contributed to the failure.
 
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. 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 that when the anesthesiologist tried to puncture an a-line with the bd insyte¿ autoguard¿ shielded iv catheter, the catheter would not thread properly. When inserting a second catheter the first catheter was cut and broke the tip off into the patient¿s body. The patient needed an ope to have the piece removed.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTERVASCULAR 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 Key7129514
MDR Text Key119057322
Report Number1710034-2017-00460
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Catalogue Number381823
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
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 Treatment Data
Date Received: 12/19/2017 Patient Sequence Number: 1
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