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

Catalog Number 382533

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle of a bd insyte¿ autoguard¿ bc shielded iv catheter broke in the patient¿s arm and required surgical intervention to remove.There was no additional information reported.

Manufacturer Narrative

There were two investigations done for this reportable event.One prior to the unit being received and examined and one after.Event description: part no: 382533 batch no: 7339578 it was reported that the iv needle broke in the patient's arm and required surgery to have the piece removed.Device/batch history record review was performed on the lot number 7339578.The lot number was built on afa line 10, from (b)(6) 2017 thru (b)(6) 2017.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the 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.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.Although observations and testing could not be performed because a sample was not received for investigation, a comparison photo was submitted for review.The photo displayed two 20ga catheter/adapter assemblies.The catheter tubing on the right was longer in length than the catheter tubing on the left.The taper of the taper of the catheter tip was missing from the shorter catheter.The photo submitted for review confirmed the needle thru catheter.The catheter/adapter assembly demonstrated evidence of having been speared thru.The customer experienced was confirmed based on the evaluation that was performed on the returned unit.Received one used iag/bc 20ga catheter/adapter assembly from the lot number 7339578.Visual/microscopic examination showed the tip of the used catheter tubing assembly was missing.The catheter tubing edges at the area of separation were uneven and the surface of the tubing was smooth.The characteristic v shape of a spear thru in the catheter tubing and cut/slit that goes thru the area of separation.Measurement: using a toolmaker microscope measured the length of the catheter/adapter from the luer end of the adapter.The length was approximately 1.882 inches long.The rest of the catheter tubing was not returned.The target length is 2.100 and lsl is 2.094.The returned used catheter/adapter assembly provided for evaluation revealed the tip of the catheter tubing was missing.The evidence provided does not confirm that the catheter/adapter was not functioning correctly during the period of infusion.There was not enough physical evidence to confirm or support manufacturing process related issues for the reported defect.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: 7444722
• MDR Text Key: 106004186
• Report Number: 1710034-2018-00187
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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: 11/30/2020
• Device Catalogue Number: 382533
• Device Lot Number: 7339578
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention