MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381444

Device Problem Mechanical Problem (1384)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the safety mechanism on the 18 g x 1.16 in.Bd insyte¿ autoguard¿ shielded iv catheter did not function properly leaving the needle exposed.There was no report of serious injury or medical interventions.

Manufacturer Narrative

Investigation: a total of (b)(4) units were built on afa line 18 and packaged on packaging line 8 starting on mar 8, 2017 through mar 14, 2017.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and 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.Set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and barrel un-seated-cracked) were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Received one used iag 18ga unit and an empty/open package from lot number 7059836, the unit consisted of a safety barrel/needle assembly and a needle cover.The unit was received with the needle partially retracted into the safety barrel.Damage (cracks, stress marks) was observed on the safety barrel.The cannula was pushed into the out position, the cannula was not bented, scratched or pinched and there was no visible damage on the hub or the spring.Retraction was not successful; the damage found on the safety barrel prevented the needle/hub assembly from fully retracting.There was damage (cracks, stress marks) observed on the safety barrel of the unit returned for evaluation.The failure of needle retraction failure was confirmed with evaluation performed on the unit received for evaluation.The needle retraction failure described in the incident report was potentially caused by the damage (cracks, stress marks) found on the safety barrel.The unit received had been used; consequently it is unknown where this damage occurred (manufacturing/user/transit).

• Brand Name: 18 G X 1.16 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: 6899070
• MDR Text Key: 88254172
• Report Number: 1710034-2017-00213
• Device Sequence Number: 1
• Product Code: FOZ
• 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: consumer,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

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: 02/29/2020
• Device Catalogue Number: 381444
• Device Lot Number: 7059836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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