MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381034

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem Pain (1994)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: 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 with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with needle retraction failure.It was stated by the consumer ¿while installing the catheter, the patient complains of a sharp pain.Failing to insert the catheter in the vein, the hcw tries to press the white button of the device so that the needle retracts, without success.She then removes the catheter and notes that the needle has pierced through the plastic of the catheter.¿ there was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd insyte autoguard bc shielded iv catheter there was an issue with needle retraction failure.It was stated by the consumer ¿while installing the catheter, the patient complains of a sharp pain.Failing to insert the catheter in the vein, the hcw tries to press the white button of the device so that the needle retracts, without success.She then removes the catheter and notes that the needle has pierced through the plastic of the catheter.¿ there was no report of injury or further medical intervention.

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: device returned to manufacturer: no.

Manufacturer Narrative

H.6.Investigation summary: device/batch history record review: the lot number was built on afa line 11, from jan 31, 2018 thru feb 3, 2018.Review of the dhr revealed all required challenges, set up and in process samples according to the quality plan were performed and passed per specifications.1 non-related qn (200731604-¿leaking beyond the plug¿) was initiated and disposition of the product, root cause and corrective action were applied according to the quality control plan.The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: rm5835 rev 12 version j 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: observations and testing could not be performed because units were not provided for investigation of this incident.Investigation conclusion: relationship of device to the reported incident: indeterminate based on previous investigation 411052-441375: needle through catheter failure: the v shaped cut observed on the catheter tubing is supporting evidence the damage was caused by manipulation (re-cannulation) of the device.A definite source that caused the damage observed on the catheter was indeterminate, it is unknown if it happened during manufacturing or during/prior use.Ifu for insertion: as stated within the training brochures, catheters should be rotated 360 degrees prior to insertion.This process should assist penetration and threading process.After the tip adhesion has been removed by rotating the catheter, the catheter should be seated to ensure the correct catheter placement exists for ease of penetration.Breaking tip adhesion also promotes a smoother threading process.Instructions to rotate the catheter prior to insertion are contained in the ifu.Based on previous investigation: needle retraction failure: the returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect described in the event description could not be confirmed or replicated.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with needle retraction failure.It was stated by the consumer ¿while installing the catheter, the patient complains of a sharp pain.Failing to insert the catheter in the vein, the hcw tries to press the white button of the device so that the needle retracts, without success.She then removes the catheter and notes that the needle has pierced through the plastic of the catheter.¿ there was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with needle retraction failure.It was stated by the consumer ¿while installing the catheter, the patient complains of a sharp pain.Failing to insert the catheter in the vein, the hcw tries to press the white button of the device so that the needle retracts, without success.She then removes the catheter and notes that the needle has pierced through the plastic of the catheter.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Correction: another supplemental mdr pr 529081 was created in duplicate of this report.This information will supercede that report which has been closed/canceled.Investigation summary: device/batch history record review showed the dhr was had been previously reviewed for pr 411052.The lot number was built on afa line 11, from jan 31, 2018 thru feb 3, 2018.Review of the dhr revealed all required challenges, set up and in process samples according to the quality plan were performed and passed per specifications.1 non-related qn (200731604-¿leaking beyond the plug¿) was initiated and disposition of the product, root cause and corrective action were applied according to the quality control plan.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing could not be performed because units were not provided for investigation of this incident.Although units were not provided for this complaint the failure mode was confirmed based on previous investigation pr 411052-441375.The v shaped cut observed on the catheter tubing is supporting evidence the damage was caused by manipulation (re-cannulation) of the device.A definite source that caused the damage observed on the catheter was indeterminate, it is unknown if it happened during manufacturing or during/prior use.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.

• 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 Key: 7655876
• MDR Text Key: 113179034
• Report Number: 1710034-2018-00409
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 381034
• Device Lot Number: 8026983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other