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

Catalog Number 382523

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that the iv cannula of the bd insyte autoguard bc shielded iv catheter with blood control split during insertion.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that the iv cannula of the bd insyte¿ autoguard¿ bc shielded iv catheter with blood control split during insertion.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: female.Event attributed to: other.Device single use?: no.Device returned to manufacture: no.Investigation summary: a complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of catheter defective / damaged with lot #6343529 regarding item #382523.Dhr review; was conducted for this investigation which disclosed the following: lot 6343529; was built and packaged on afa line 11 from 12dec2016 through 22dec2016 for the quantity of (b)(4).All challenge, set-up and in process samples were performed in accordance to the quality control plan and all passed per specifications.Dhr review disclosed no indication of the defect as it was noted that there were no ip quality notifications initiated during production of this lot that would impact upon the quality of the product.There was one temporary deviation (td 2016-78) in affect during the build of this lot.Sap (qn) database review; was conducted for this investigation, which disclosed the following: there were no reject activity findings relevant to the defect associated with the lot number provided for this incident.No qns were initiated for this lot.Two photos were provided for this incident which revealed a 22g bd insyte autoguard unit which was out of packaging and used.The unit consisted of the catheter/adapter assembly and the needle/hub assembly with grip and barrel.There was also a top web (tyvek/label) from a 22 ga bd insyte autoguard from lot 6343529.Photos revealed the needle was piercing through the tubing wall near the nose of the adapter; indicative of a base spear thru.There were traces of thick media present within the catheter tubing wall and in the flashback chamber of the needle assembly.The media present within the catheter tubing and flashback chamber was evidence that the catheter and needle were intact at time of puncture/insertion.Therefore there was no physical evidence that the failure was manufacturing process related.Analysis of peura (end user risk analysis) disclosed that due to low occurrence and limited severity, current risk is acceptable.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.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: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7778138
• MDR Text Key: 117017921
• Report Number: 1710034-2018-00537
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 382523
• Device Lot Number: 6343529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other