MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.16 IN. (1.1 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382534

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

User facility reported event to fda.Medwatch uf/importer report# 310045-2017-0001.Medwatch report filed.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 while using a 20 g x 1.16 in.(1.1 mm x 30 mm) bd insyte¿ autoguard¿ bc shielded iv catheter, the catheter broke from the hub and remained in the patient.Surgical intervention was needed to remove.

Manufacturer Narrative

Investigation: -dhr review was performed on the following lot number: 7131877 ¿ the lot number was built on (b)(4).Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications (b)(4), 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.Qn / sap database review: yes.Reason: the review of the qn/sap database is required for a s3 - o1 level b investigation per (b)(4), this is a level b investigation.Findings: the qn reviewed revealed no related reject activity for the sub-assembly lot number associated with this incident.Visual analysis observations and testing: received one used iag/bc 20ga retracted unit, unused catheter/ adapter assembly, and a package label from the lot number 7131877.The used returned unit consisted of the used retracted needle/safety barrel and catheter/adapter assemblies.Visual/microscopic examination: observed the tip of the used catheter tubing assembly was missing using the returned unused catheter/adapter assembly; compared the length to the returned used catheter/adapter.The tip of the used catheter tubing was missing observed the catheter/adapter assembly revealed the area of separation was on an angle in a v shape pattern, which is a characteristic of a spear through.The catheter tubing edges were smooth with little strings/flashing measurement: using a toolmakers microscope, measured the length of the catheter tubing from the luer end of the adapter to the tip of the catheter tubing (full length).The length was approximately 1.906 inches long, not acceptable per specification (b)(4)investigation samples(s) meet manufacturing specifications: no, the returned used unit provided for evaluation revealed the tip of the used catheter tubing assembly was missing.Conclusions: the defect of cath broke/separated after placement; as stated in the subject of the pir was confirmed with the returned used unit.Did the evaluation confirm the customer¿s experience with the bd product? yes; the customer experienced was confirmed based on the evaluation that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? n/a; it was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed.Root cause: relationship of device to the reported incident: indeterminate.Comment: 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.Corrections and capa corrective action project / capa (#): 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.Other action taken: product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.These inspections are performed by operators and/or process control technicians to ensure any gross process changes are identified.If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.

• Brand Name: 20 G X 1.16 IN. (1.1 MM X 30 MM) 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
• 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: 6852994
• MDR Text Key: 85447566
• Report Number: 1710034-2017-00173
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 382534
• Device Lot Number: 7131877
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• 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): Required Intervention
• Patient Age: 40 YR