MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381512

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2017

Event Type  malfunction  

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 and/or device history review, a supplemental report will be filed.

Event Description

It was reported that blood leaked from a hole in the 24 g x 0.75 in.Bd insyte¿ autoguard¿ shielded iv catheter.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation: dhr review was performed on the following lot number: 6334962 ¿ the lot number was built on afa line 4, from december 7, 2016 thru december 8, 2016.Per review of the dhr it was concluded that 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.In process sampling for needle thru catheter were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Qn / sap database review: no.Reason: a review of the qn/sap database is not required for a s1 ¿ o1 level a investigation per (b)(4).The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: (b)(4) version i was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Visual analysis: observations and testing: received one used iag 24ga unit with an opened package from the lot number 6334962.The unit consisted of the retracted needle/safety barrel and the catheter/adapter assemblies.Visual/microscopic examination: observed there was characteristic v shape of a spear thru in the catheter tubing approximately ¼ of an inch below the catheter tip.Water/air leak test: air bubbles were observed coming from the area of the v shape slit in the tubing.Test description method no results visual/microscopic, n/a, see observations and testing.Water/air leak test, (b)(4), see observations and testing.Investigation samples(s) meet manufacturing specifications: no, the returned unit provided for evaluation displayed the characteristic v shape of a spear thru which did leak.Conclusions: the defects blood excess/splash/spill/exposure and catheter defective/damage of as stated as the reported codes were confirmed.The defect associated with this incident report was caused by the cannula spearing the catheter wall.Did the evaluation confirm the customer¿s experience with the bd product? yes; the customer experienced was confirmed based on the evaluation and testing that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? n/a; it was not necessary to achieve reproduction of the customer¿s experience, as the defects was confirmed.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate.Comment: it is uncertain whether the needle spearing the catheter wall which was observed as the cause of the defects was caused by manipulation of the device by the user or by the manufacturing process.The unit was returned used, retracted and in an opened package.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: during the assembly process there is a 100 percent automated vision system inspection for tip spear, base spear and lie distance.Defect of this type found during manufacturing should be discarded.

• Brand Name: 24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7006996
• MDR Text Key: 91952618
• Report Number: 1710034-2017-00304
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815129
• UDI-Public: 30382903815129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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 Expiration Date: 11/30/2019
• Device Catalogue Number: 381512
• Device Lot Number: 6334962
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other