MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382533

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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 that a 20 g x 1.00 in.(1.1 mm x 25 mm) bd insyte¿ autoguard¿ bc shielded iv catheter with blood control technology, failed to function properly post use.The nurse attempted to push the safety button.Which was not successful.She tried to retract the stylet and it was caught on the catheter hub which pulled the entire system out including the catheter.There was no report of injury or medical intervention following this event.

Manufacturer Narrative

Investigation summary: investigation completed by: (b)(6), pr #: (b)(4), part #: 382533, lot #: unknown.Complaint: needle retraction failure s1.Event description: iv nurse tried to push the safety button it did not work, she tried to retract the stylet and it was caught on the catheter hub and pulled the entire system out including the catheter.A 20 gauge blood control.The iv nurse did not keep the package to be able to tell you the lot #.Needle will not retract.Lot analysis: device/batch history record review: no.Reason: although this incident is classified as mdr the lot number associated with the investigation was unknown.Findings: n/a.Qn / sap database review: no.Reason: the qn/sap database review is not required for level a investigations per (b)(4), findings: n/a.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 non-retracted iag bc 20ga unit within a bottom film (packaging) blister.All components were present.Visual/microscopic examination: observed the assembly (catheter/needle) was slightly bent within the needle cover, upon removing the needle cover and the adapter the bend on the cannula was confirmed.Functional test (needle retraction): the adapter was placed back into the cannula assembly and the white button was pushed to attempt needle retraction, the retraction was successful.Test description method no results visual/microscopic, n/a, see observations and testing.Functional test, n/a, see observations and testing.Investigation samples(s) meet manufacturing specifications: no.The unit received for evaluation had a bent needle.Conclusions: the needle retraction failure could not be confirmed.The unit retracted successfully when the white button was pushed.The cannula of the received unit was received bent.Did the evaluation confirm the customer¿s experience with the bd product? no.The needle retraction failure that the customer experienced was confirmed with the evaluation and testing performed in the unit returned for investigation.Were we able to reproduce the customer's experience with the bd product? yes.The failure experienced by the customer was reproduced in the laboratory.Was the device used for treatment or diagnosis? treatment.Root cause description root cause: root cause: relationship of device to the reported incident: indeterminate.Needle retraction failure: there was no physical evidence confirming and supporting manufacturing process related issues for the defect failure experienced by the customer.The unit retracted successfully when the white button was pushed.Needle bent (observed during investigation): it is uncertain whether the failure was caused by manipulation of the device prior to insertion or by the manufacturing process.

• Brand Name: 20 G X 1.00 IN. (1.1 MM X 25 MM) 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6960253
• MDR Text Key: 90649067
• Report Number: 1710034-2017-00272
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 382533
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other