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

Catalog Number 381434

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

Medical device lot #: unknown.It was reported that potential lot numbers for this incident may have been 5275717 or 5273583.Medical device expiration date: 9/30/2018 is the expiration date for both potential lot numbers, 5275717 and 5273583.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: for lot number 5275717: 10/2/2015.For lot number 5273583: 9/30/2015.

Event Description

It was reported that after catheter insertion with a bd insyte autoguard shielded iv catheter, the needle did not fully retract after the safety mechanism was activated and a nurse received a needle stick injury while placing the device into a sharps container.The nurse followed up with his/her employee health department and received routine post exposure lab work but no prophylaxis was given.The lab results were negative and the nurse will not have continued follow up with employee health.

Manufacturer Narrative

Results: two used and retracted units from an unknown lot number, a piece of paper top web from the lot number 5275717, and an opened package from the lot number 5273583 were received for evaluation.A visual inspection of the units showed that the needles were retracted and the safety activation buttons were depressed.No mechanical or physical damage to the springs or needle hubs was observed.The needles were pushed and repositioned to the out position; observed there was no mechanical/physical damage to the springs or needle hub or grip.There was no evidence of adhesive on the buttons, grips or hubs.A functional test (needle retraction) was performed by repositioning the needle to the out position and depressing the safety activation button at which point the needle retracted fully within the safety barrel.The retraction was successful, meeting no resistance.A review of the device history records revealed no irregularities during the manufacture of the potential lot numbers 5275717 and 5273582.Conclusion: an absolute root cause for this incident cannot be determined as the evaluated samples and review of the device history recorded revealed no irregularities.

• Brand Name: 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: 5324424
• MDR Text Key: 34274997
• Report Number: 1710034-2015-00025
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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?: No
• Device Operator: Nurse
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 381434
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention