MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383512

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Swelling (2091); Tissue Breakdown (2681)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

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 the patients foot developed blisters and a wound, it also became swollen and blue.The patients 22 g x 1.00 in.Bd nexiva¿ closed iv catheter system was removed and a new one was placed.Patient received cleaning and bandaging.

Manufacturer Narrative

Investigation: lot analysis device/batch history record review: yes.Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr).This incident is a mdr.Findings: -dhr review was performed on the following lot number: 7069702 ¿ the lot number was built on (b)(4).Per specifications in (b)(4) it was concluded that all required challenges samples and testing was performed, in accordance with the set-up and 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 # (b)(4) was initiated for raw materials (see details below) qn / sap database review: yes.Reason: the review of the qn/sap database is required for s3-o1 level b investigation per (b)(4), this is a level b investigation.Findings: the reviewed revealed qn # (b)(4) (suspect film thickness oos) that could be associated with this incident.The qn was disposition to use.We reached out to the vendor who confirmed that the material thickness was within specifications.(b)(4).Eura review: yes.Reason: mdr investigation: findings: reviewed eura (b)(4) 12(k) and found that the risk of ¿inflammation¿ has been assessed and is characterized as a s2.With the low occurrence of this defect the risk is acceptable.Visual analysis.Observations and testing: received one unused nexiva 22ga unit in sealed package from the lot number 7069702.Package leak test: testing was performed using a lab supplied iso 20ga needle/hub assembly attached to the male luer fitting of the station.Performed the leak test by submerging the package beneath water line; piecing the needle/hub into the cavity.There were no leaks or opened seals.Visual/microscopic examination: the bevel area had the proper bevel cuts.Lie distance was within the acceptable range of.001 - 0.032 inches.Observed the needles were not bent, pinched or gripper damage to the needles.Cannula tip quality was acceptable.No holes, kinks, splits, or wrinkles were found in the tubing.Catheter tips were graded a 4, acceptable.Test description method no results.Package leak teat qcge ¿ 144 see observations and testing.Visual/microscopic n/a see observations and testing.Lie distance nexiva needle catheter see observations and testing assembly drawing (b)(4).Cannula tip quality n/a see observations and testing catheter tip rating tip-009 see observations and testing.Investigation samples(s) meet manufacturing specifications: yes, the returned unit provided for evaluation performed and met manufacturing specification requirements.Conclusions: the defect of irritation/inflammation; stated in the subject of the pir was not confirmed.No physical evidence to confirm or to support manufacturing process related issues for the defect.The returned unit did not display any adverse characteristics that would contribute to the defect the customer complained about.The defect described in the incident report could not be confirmed or replicated with the returned unit.Did the evaluation confirm the customer¿s experience with the bd product? no; the customer experienced was not confirmed based on the evaluation and testing that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? no; the customer experienced was not confirmed based on the evaluation and testing that was performed on the returned units.Was the device used for treatment or diagnosis? treatment root cause.Relationship of device to the reported incident: indeterminate comment: the pyrogen samples passed all testing (see (b)(4)¿ pyrogen test results).The finished product testing report was reviewed; all pallets passed (b)(4) corrections and capa.Corrective action project / capa (#): a formal corrective action will not be initiated at this time.A manufacturing related root cause could not be identified.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: 22 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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: 6831113
• MDR Text Key: 83993736
• Report Number: 1710034-2017-00176
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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: 02/29/2020
• Device Catalogue Number: 383512
• Device Lot Number: 7069702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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