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

Catalog Number 38103414

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

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, a supplemental report will be filed.

Event Description

It was reported during use of the bd insyte¿ autoguard¿ bc the device had a hole in it. There was no report of blood exposure or damage to patient. There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: device/batch history record review findings: this iv sub-assembly lot (7226519) was built on afa line 9 on 19aug2017 through 21aug2017 and bulk packaged from afa line 9 for the quantity of (b)(4) units. Per review it was noted that there were no rejected findings throughout the build of this lot that would impact upon the quality of the product of the catheters. Set-up and in process samples including (but not limited to) adapter damage/cracked (interior-exterior), damaged component and catheter leak test passed per specification. 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. Sap (qn) database review findings: subject code was an s1 severity ranking. Review was conducted for this mdr- level a investigation; as a result of the review there were no reject activity findings relevant to the defect associated with the iv sub-assembly lot number provided for this incident. Observations and testing: although a sample was not returned, a photo was provided for evaluation of this incident. The photo revealed the unit was of a pink 20g blood control adapter which had media present in the adapter. Observed a void in the wall of the adapter. The void was oval-shaped and ran linear with the adapter starting at mid body (adapter) and running towards the threads. Also visible in the photo was a partial view of the grip assembly and fully retracted needle and a miscellaneous injection site which revealed traces of media. Conclusions: confirmation of the failure of needle hub defective / damaged, as stated in the description of the complaint was conclusive based evaluation of the photo provided for this incident. Confirmed the photo provided for this incident displayed evidence of a hole in the adapter. There was no evidence to confirm or support manufacturing process related issues for the defect reported in the product incident report.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7280492
• MDR Text Key: 100556812
• Report Number: 1710034-2018-00047
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 38103414
• Device Lot Number: 7332932
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 02/19/2018 Patient Sequence Number: 1