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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
Date received by manufacturer: should be 09/27/2017.
 
Manufacturer Narrative
Investigation summary: the corrective action statement is approved / authorized and final review of the complaint will be conducted by the designated complaint handling unit (dchu). Lot #: 7157557, complaint: foreign matter, event description: customer reported the catheter tip was uneven and fm seems to be attached. (b)(4). Lot analysis. Device/batch history record review: yes. Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr). Findings: lot 7157557; was built and packaged on afa line 11 on 07jun2017 thru 11jun2017 for the quantity of (b)(4). Review of dhr revealed all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans. Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pr. Sap (qn) database review: yes. Reason: this database tracks any issue during production that would affect product quality findings: subject code was an s1 severity ranking. Review was conducted for the mdr - level a investigation; as a result of the review there were no reject activity findings relevant to the defect stated in the pr associated with the potential lot numbers provided for this incident. Visual analysis observations and testing: o although units were not received for investigation; photos were provided for observation of this incident. ¿ three photos ((b)(4)) revealed; a 22 g bd iag blood control unit out of packaging from lot 7157557; the catheter adapter was intact. ¿the remaining three photos ((b)(4)) revealed fm near/at the tip of the catheter tubing. Visual/microscopic examination: photos: ¿ there was fm (blue, black and brown particulate, black specs and a clear substance) on the catheter tubing in the area below the tip of the tubing. The clear substance was determined to be lubrication (lube). The particulate was determined to be fibers. The specks were determined to be soiled lube which was carried on by the clear lube. Note: the lubrication is a non-foreign and is part of the process. ¿ it could not be determined if the fm exceed 0. 2 square millimeters measured per tappi dirt estimation chart without the actual unit for testing. Test description method no results visual/microscopic n/a see observations and testing tappi chart qcge-34 see observations and testing investigation samples(s) meet manufacturing specifications: no, foreign matter was observed on the catheter tubing. Investigation conclusion: conclusions: o confirmation of the subject of foreign matter, as stated in the pir, was conclusive with the photos provided for investigation. O confirmed there were non-foreign (soiled lubrication substance) which was physical evidence to confirm and support manufacturing process related issues for the reported defect on the returned unit. O confirmed there fm (fibers and specs) on the catheter tubing; which is indeterminate how it was introduced to the unit. Root cause description: did the evaluation confirm the customer¿s experience with the bd product? yes: confirmation of the failure of foreign matter was conclusive with the investigation of the photos provided for this incident. Were we able to reproduce the customer's experience with the bd product? no; reproduction of the customer¿s experience of fm noted in the pr was not necessary as the reported defect was confirmed. Was the device used for treatment or diagnosis? treatment root cause relationship of device to the reported incident: manufacturing ¿ the clear fm substance was determined to be lube (part of the manufacturing process) and soiled lube. Comment: it is indeterminate how the fm (fibers and specs) was introduced to the unit as the unit was out of packaging rationale: corrections and capa corrective action project / capa (#): 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. Other action taken: product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections. These inspections are performed by operators and/or process control technicians to ensure any gross process changes are identified. If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan. Note: 5s cleaning is performed by each shift to minimize the potential for introducing foreign matter to the product. Manufacturing has been notified of this incident and the findings in respect to the subject of fm (soiled lube).
 
Event Description
It was reported that the 22 g x 1 in. (1. 3 mm x 30 mm) bd insyte¿ autoguard¿ bc shielded iv catheter tip was uneven and had foreign matter attached. Found before use. No serious injury or medical intervention noted.
 
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Brand Name22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC 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 Key6980000
MDR Text Key248630349
Report Number1710034-2017-00264
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number381023
Device Lot Number7157557
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2017
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: 10/26/2017 Patient Sequence Number: 1
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